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

Catalog Number	400SMTXSFT2H03
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was implanted and not returned for evaluation.Aneurysm rupture is a known and anticipated complication with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted in the patient.
Event or Problem Description
On (b)(6) 2018 the patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached two smart coils using a non-penumbra microcatheter.While attempting to deploy a third smart coil the physician felt resistance while advancing the smart coil, and the aneurysm ruptured as a smart coil was being placed.Therefore, the patient was immediately administered 15 mg of protamine.The smart coil was successfully implanted, and the ruptured aneurysm was successfully treated by implanting additional smart coils.After the procedure, the patient underwent a computed tomography scan (ct scan).The ct scan showed subarachnoid contrast extravasation.The patient was somnolent, lethargic, had a top of head headache, left perioral droop, and was confused on (b)(6) 2018.Chronic left hemiparesis was unchanged.A ct scan on (b)(6) 2018 showed interval improvement of the subarachnoid hemorrhage.On (b)(6) 2018, the patient was alert and oriented.On (b)(6) 2018, the subject was alert and oriented but complained of headache, neck stiffness, and some generalized weakness.On (b)(6) 2018, the patient¿s encephalopathy was deemed resolved, and the patient was discharged home.This ruptured aneurysm was adjudicated to be a serious adverse event with a definite relationship to the smart coil system and the 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: 7545762
• Report Number: 3005168196-2018-01071
• Device Sequence Number: 10795822
• Product Code: HCG
• UDI-Device Identifier: 00814548015316
• UDI-Public: 00814548015316
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: Physician
• Device Expiration Date: 12/12/2022
• Device Catalogue Number: 400SMTXSFT2H03
• Device Lot Number: F81009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/25/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 113