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Reporting Scenario # 2

Reporting Scenario # 2. September 18, 2005. Scenario # 2. Mr. Hall, 62 yr old man with acute MI, is to receive autologous mobilized PBSCs delivered via intracoronary catheter 5 days post MI. Clinical Study has 2 arms, patients receive either PBSCs or control (placebo).

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Reporting Scenario # 2

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  1. Reporting Scenario # 2 September 18, 2005

  2. Scenario # 2 • Mr. Hall, 62 yr old man with acute MI, is to receive autologous mobilized PBSCs delivered via intracoronary catheter 5 days post MI. • Clinical Study has 2 arms, patients receive either PBSCs or control (placebo). • Investigator is blinded to cell therapy arm.

  3. Scenario # 2 • Shortly after infusion, the patient suddenly develops ventricular fibrillation, requiring electrical defibrillation. • Normal sinus rhythm is restored. • Catheter is removed. • Patient shows frequent ventricular premature beats and runs of ventricular tachycardia (not present before infusion).

  4. Scenario # 2 • Is this an adverse event? • Yes.

  5. Scenario # 2 • If an adverse event, is the event serious? Life-threatening? Unexpected? • This AE meets the FDA & ICH definition of Serious AE. • This AE meets the FDA definition of Life Threatening.

  6. Scenario # 2 • Is the Unexpected? • That depends on the information presented in the Investigator Brochure, protocol and/or the informed consent. NOTE: The possibility of this event (acute arrhythmia) should be described in these documents.

  7. Scenario # 2 • Is this reportable to the FDA? If so, how should it be reported? • Since the AE was life-threatening, it should be reported to the FDA by phone or fax within 7 calendar days, written report within 15 calendar days.

  8. Scenario # 2 • What else should you do? • Report the event to the IRB as per SOP. • Investigate for potential causes of ventricular fibrillation: Is it related to the cells? The catheter? The infusion technique?

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