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

Model Number	400SMTXSFT0308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, hematoma or hemorrhage at the site, aneurysm rupture, intracranial hemorrhage, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2020, the patient underwent a coil embolization procedure in the right fetal posterior cerebral artery (pca) using penumbra smart coils (smart coils), a non-penumbra stent, a non-penumbra microcatheter and a guidewire.During the procedure, 10 mg of verapamil and aggrastat were administered prior to stent placement in the vessel.The physician then advanced the microcatheter over the guidewire and into the pca.Next, the stent was placed from the pca to the internal carotid artery (ica), covering the aneurysm.The physician then implanted four smart coils in the target vessel.However, upon placement of the forth smart coil, the angiography demonstrated contrast extravasation indicative for aneurysm rupture.Subsequently, three additional smart coils were implanted in the target vessel and protamine was administered to control extravasation.Following the coil embolization, there was complete occlusion of the aneurysm and the control angiography demonstrated no evidence of branch vessel occlusion and no further extravasation.On (b)(6) 2020, the patient was discharged home in stable condition.The aneurysm perforation was reported to be a serious adverse event with a definite relationship to the smart coil and index procedure.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10837985
• Report Number: 3005168196-2020-01987
• Device Sequence Number: 11581898
• Product Code: HCG
• UDI-Device Identifier: 00814548015361
• UDI-Public: 00814548015361
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 10/20/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2025
• Device Model Number: 400SMTXSFT0308
• Device Catalogue Number: 400SMTXSFT0308
• Device Lot Number: F97348
• 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: 10/20/2020
• Initial Report FDA Received Date: 11/13/2020
• 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: Other
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005