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

Model Number	400SMTHXSFT1H02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/15/2021
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 dissection, or perforation, aneurysm rupture, intracranial hemorrhage, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2021-01774.
Event or Problem Description
On (b)(6) 2021, the patient underwent a coil embolization procedure to treat a ruptured aneurysm in the left internal carotid artery (ica) and posterior communicating (pcom) artery using penumbra smart coils (smart coil), a non-penumbra microcatheter and a guidewire.During the procedure, the physician implanted eight smart coils in the target location using the microcatheter.While attempting to advance the next smart coil, the physician was unable to advance the smart coil at all past its initial position within its introducer sheath.It was reported that multiple attempts were made to advance the smart coil; however, they were unsuccessful.Therefore, the smart coil was removed.Next, the physician implanted five smart coils in the target location using the microcatheter.After advancing the next smart coil into the target location, the physician attempted to reposition the microcatheter to find a good position for the smart coil.While repositioning the microcatheter, the smart coil and microcatheter extended beyond the aneurysm wall which caused a perforation.The physician then repositioned the microcatheter and smart coil and detached the smart coil in the target location.Additional smart coils were then implanted in the target location to bridge the point of perforation and close the portion of the aneurysm dome.Subsequently, it was noticed that there was a brief and small amount of contrast extravasation which quickly sealed.It was reported there was no change in the patient¿s vitals.The event was considered resolved the same day (b)(6) 2021.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: 12297651
• Report Number: 3005168196-2021-01775
• Device Sequence Number: 16939104
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2021
• 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: 06/25/2025
• Device Model Number: 400SMTHXSFT1H02
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F98554
• 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: 07/15/2021
• Initial Report FDA Received Date: 08/09/2021
• 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; Required Intervention
• Patient Age: 87 YR
• Date Report Sent to FDA: 01/01/2005