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

Catalog Number	400SMTHXSFT0304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Neurological Deficit/Dysfunction (1982)
Date of Event	11/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2017-00161, 3005168196-2017-00333.
Event or Problem Description
The patient underwent a coil embolization procedure using penumbra smart coils (smart coils).There was no report of a device malfunction with the smart coils.Seven days after the procedure, the patient had a stroke and was treated with ativan.The reported stroke was believed to be possibly related to the smart coil system.On (b)(6) 2017, the patient suffered another possible stroke and was admitted to the hospital.As of 02/092017, it is unknown what the patient's condition is.Please note that the manufacturer has requested further information from the study site; however, as of 03/07/2017, no additional information has been provided.
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Neurological deficits including stroke is a known and potential complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported stroke was a potential complication related to the use of the penumbra smart coil system.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.The device was implanted into the patient.
Event or Problem Description
Updated information based on additional clarification received on 08/28/2017 and 09/18/2017: on (b)(6) 2016, the patient underwent a coil embolization procedure using penumbra smart coils (smart coils).Four days after the procedure, the patient had a stroke.The reported stroke was also believed to be possibly related to the aneurysm/malformation disease state but unrelated to the angiographic procedure.The second stroke experienced on (b)(6) 2017 was believed to be possibly related to the aneurysm/malformation disease state but unrelated to the smart coil system and angiographic 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: 6395953
• Report Number: 3005168196-2017-00334
• Device Sequence Number: 11107087
• Product Code: HCG
• UDI-Device Identifier: 00814548015774
• UDI-Public: 00814548015774
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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: Physician
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: 400SMTHXSFT0304
• Device Lot Number: F66819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR