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

Catalog Number	400SMTXSFT0408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Paresis (1998)
Date of Event	11/02/2017
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, non-conformance, or misuse that contributed to the reported event.Potential adverse events with the penumbra smart coil (smart coil) system include cerebral ischemic events and neurological deficits including cerebrovascular accident (cva) and are included in the labeling.Therefore, it was determined that the reported cerebrovascular accident was a potential complication related to the use of the smart coil system.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 1.3005168196-2017-02099, 2.3005168196-2017-02100, 3.3005168196-2017-02102, 4.3005168196-2017-02103.The device was implanted in the patient.
Event or Problem Description
The patient underwent a coil embolization procedure on (b)(6) 2017 using five penumbra smart coils.Within two hours after the procedure, the patient experienced acute neurologic decline and became hemiparetic.The patient underwent an endovascular revascularization therapy (ert) with a successful thrombolysis for acute stroke therapy and recanalization of the right middle cerebral artery (mca), achieving tici grade 3 flow.This event was resolved on (b)(6) 2017.The cerebrovascular accident (cva) was adjudicated to be a serious adverse event with a definite relationship to the disease state, a definite relationship to the procedure, and a probable relationship to the smart coil system.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7068216
• Report Number: 3005168196-2017-02101
• Device Sequence Number: 67682
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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 Catalogue Number: 400SMTXSFT0408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/29/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 49 YR