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

Catalog Number 4002C0935

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombus (2101); Weakness (2145); Dysphasia (2195)

Event Date 08/25/2016

Event Type  Injury  

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, 3005168196-2016-01373, 3005168196-2016-01374.The device was implanted in the patient.

Event 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.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2016-01372.1.Section b.Box 2.Outcomes attributed to adverse event this report is associated with mfr report numbers: 1.3005168196-2016-01366.2.3005168196-2016-01367.3.3005168196-2016-01368.4.3005168196-2016-01369.5.3005168196-2016-01370.6.3005168196-2016-01371 7.3005168196-2016-01373.8.3005168196-2016-01374.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5975430
• MDR Text Key: 55561422
• Report Number: 3005168196-2016-01372
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/29/2023
• Device Catalogue Number: 4002C0935
• Device Lot Number: F67129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR