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

Catalog Number	400SMTSFT0406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	03/09/2018
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.A potential adverse event with the penumbra smart coil system include embolic stroke and other cerebral ischemic events and is included in the labeling.Therefore, the reported acute ischemic left anterior cerebral artery (aca) stroke is considered an anticipated procedural complication.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-00802, 3005168196-2018-00803, 3005168196-2018-00805, 3005168196-2018-00806, 3005168196-2018-00807, 3005168196-2018-00808.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician placed seven smart coils.During the procedure, the patient suffered an acute ischemic left anterior cerebral artery (aca) stroke and the hospital staff administered thrombolytics intra-arterially, followed by balloon angioplasty and a non-penumbra stent device.As of (b)(6) 2018, the patient remained hospitalized.The acute ischemic left anterior cerebral artery (aca) stroke was reported to be a serious adverse event with probable relationship to the smart coils and definite relationship to 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: 7441723
• Report Number: 3005168196-2018-00804
• Device Sequence Number: 13726897
• Product Code: HCG
• UDI-Device Identifier: 00814548015071
• UDI-Public: 00814548015071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/22/2018

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?: No
• Operator of Device: Physician
• Device Catalogue Number: 400SMTSFT0406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/18/2018
• 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: Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 51 YR