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

Catalog Number	4006C0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	12/25/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This report is associated with mfr report numbers: 1.3005168196-2016-00255, 2.3005168196-2016-00257, 3.3005168196-2016-00258.Device was disposed of.
Event or Problem Description
The patient successfully underwent a coil embolization procedure in the right middle cerebral artery (mca) using penumbra coils 400 (pc400 coils).Six months post-procedure the patient experienced transient neurologic deficit and was treated with plavix.A magnetic resonance imaging/angiography (mri/mra) confirmed that this serious adverse effect (transient neurologic deficit) was resolved.This serious adverse effect was adjudicated to have an uncertain relationship to the pc400 coils, and an unrelated relationship to both the angiographic procedure and the aneurysm/malformation disease state.
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer? on the initial report indicated that the device was disposed of; however, this section should have stated that the device is not available for evaluation because it was implanted in the patient.(b)(4).

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5458677
• Report Number: 3005168196-2016-00256
• Device Sequence Number: 10833494
• Product Code: HCG
• UDI-Device Identifier: 00814548011769
• UDI-Public: 00814548011769
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2016

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: 11/30/2021
• Device Catalogue Number: 4006C0202
• Device Lot Number: F39712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 02/29/2016
• 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: Required Intervention
• Patient Age: 60 YR