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

Catalog Number	4002C0820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombus (2101); Weakness (2145); Dysphasia (2195)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Potential adverse events with the penumbra coil system include ischemia and neurological deficits including stroke and are included in the labeling.Therefore, it was determined that the reported ischemic stroke formation was an anticipated 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: 3005168196-2016-01366, 3005168196-2016-01367, 3005168196-2016-01368, 3005168196-2016-01369, 3005168196-2016-01370, 3005168196-2016-01371, 3005168196-2016-01372, 3005168196-2016-01373.The device was implanted in the patient.
Event or Problem Description
The patient underwent a coil embolization procedure in the left paraophthalamic artery using penumbra coil 400 (pc400's) with no complications during the procedure.However, six hours post-procedure, the patient developed aphasia, which progressed to right-sided weakness.A follow-up angiography was performed and showed decrease blood flow into the middle cerebral artery (mca) and a thrombus in the m3 branch of the left internal carotid artery (lica) was noticed.Therefore, the patient underwent a thrombectomy procedure, which partially removed the thrombus; however, a fragment of the thrombus went downstream and could not be removed.The patient was still admitted in the hospital.As of (b)(6) 2016, the patient was in stable condition.This serious adverse event was reported as an ischemic stroke and was adjudicated to have a probable relationship to the pc400's, the angiographic procedure and the aneurysm malformation.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5975455
• Report Number: 3005168196-2016-01374
• Device Sequence Number: 10860598
• Product Code: HCG
• UDI-Device Identifier: 00814548010557
• UDI-Public: 00814548010557
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/26/2016

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: 12/29/2022
• Device Catalogue Number: 4002C0820
• Device Lot Number: A62034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 09/23/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR