MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C0610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Weakness (2145)
Date of Event	06/11/2016
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.Ischemia 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 transient ischemic attack was an anticipated procedural complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2016-00970, 3005168196-2016-00971, 3005168196-2016-00972, 3005168196-2016-00973.The device was implanted in the patient.
Event or Problem Description
The patient underwent a coil embolization procedure in the choroidal segment of the right supraclinoid internal carotid artery (ica) using penumbra coil 400 coils (pc400 coils).The procedure was completed with no complications.However, the day after the procedure, the patient experienced two episodes of transient left-sided weakness.On (b)(6) 2016, a follow-up magnetic resonance imaging (mri) was performed which revealed small infarcts scattered in the right middle cerebral artery (mca) territory, which resolved on the same day.On (b)(6) 2016, the patient was discharged to a skilled nursing facility in stable condition.The small infarcts were reported to be a transient ischemic attack (tia) and a non-serious adverse event with a possible relationship to the pc400 coils, the aneurysm as well as the angiographic procedure.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5804178
• Report Number: 3005168196-2016-00969
• Device Sequence Number: 18895004
• Product Code: HCG
• UDI-Device Identifier: 00814548010502
• UDI-Public: 00814548010502
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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
• Report Date (Section B): 06/19/2016

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: 04/30/2019
• Device Catalogue Number: 4002C0610
• Device Lot Number: F20746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2016
• Initial Report FDA Received Date: 07/19/2016
• 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: Other
• Patient Age: 79 YR