MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number	400SMTSFT0820
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, hematoma or hemorrhage at the access site or entry, device malfunction, and vessel spasm, thrombosis, dissection, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a basilar bifurcation aneurysm using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician placed three smart coils into the target location using a microcatheter.While placing another smart coil, the physician noticed a preciously placed smart coil herniated into the right posterior cerebral artery with associated platelet aggregation.It was reported that the patient was treated with intravenous (iv) and intra-arterial(ia) medications which resolved the platelet aggregation over the remainder of the procedure.Also, the smart coil that herniated into the right posterior cerebral artery was stabilized with a stent.The procedure was completed using four additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10954037
• Report Number: 3005168196-2020-02193
• Device Sequence Number: 2420231
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 400SMTSFT0820
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F90712
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005