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

Model Number	400SMTHXSFT0103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	04/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Aneurysm rupture is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported aneurysm rupture was an anticipated procedural 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) 2021, the patient underwent a coil embolization to treat a rupture of an internal carotid artery (ica) and posterior communicating artery (pcom) aneurysm using penumbra smart coils (smart coils), penumbra system 3max reperfusion catheter (3maxc), balloon catheter, and a non-penumbra microcatheter.During the procedure, a rupture of the ica and pcom was noted.The physician used a balloon catheter to control the rupture.Subsequently, the balloon catheter was deflated and the clot in the m2 segment of the middle cerebral artery was removed using the 3maxc.The physician performed a computerized tomography (ct) scan post procedure that revealed minimal blood.Post procedure, patient is alert and oriented, symmetric and no drift.On (b)(6) 2021, patient was discharged home in stable condition.The rupture aneurysm was reported to be a serious adverse event with a definite relationship to the index procedure and to the smart coil.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11809548
• Report Number: 3005168196-2021-01017
• Device Sequence Number: 3646416
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2021
• 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: 11/15/2025
• Device Model Number: 400SMTHXSFT0103
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F101999
• 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: 04/16/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: Required Intervention
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005