MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Seizures (2063)
Date of Event	03/21/2017
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2017-01971.The device was not returned.
Event or Problem Description
On (b)(6) 2017, the patient underwent a thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max), a penumbra system ace 64 reperfusion catheter (ace64) and a non-penumbra stent retriever.There was no procedural complications.However, three days later, on (b)(6) 2017, the patient had a generalized tonic-conic seizure with post-seizure brachial paresis.A computerized tomography (ct) scan revealed a subarachnoid hemorrhage in the right sylvian fissure and right convexity sulci.The core lab also identified this subarachnoid hemorrhage and the patient was administered protamine sulfate.The patient was stabilized and discharged home on (b)(6) 2017 with a magnetic resonance spectroscopy (mrs) score of 2 and national institutes of health stroke scale (nihss) score of 0.A follow-up ct scan performed on (b)(6) 2017, demonstrated progression of the hematic content density of the right sylvian fissure which was less evident in the follow up study, and no other intracranial abnormalities.The investigator reported the event as a serious adverse event unrelated to ace64, other penumbra device (3max), non-penumbra device (stent retriever) and iv-rt-pa, and probable related to angiographic procedure and index stroke.On (b)(6) 2017, however, the subarachnoid hemorrhage was adjudicated by the cec chair to be a serious adverse event which was possibly related to the ace64, other penumbra device (3max), non-penumbra device (stent retriever), angiographic procedure and unrelated to index stroke.The outcome was considered to be resolved on same day as the start date.
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Hemorrhage is a known and anticipated complication with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7011514
• Report Number: 3005168196-2017-01972
• Device Sequence Number: 18957081
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 5MAXACE064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 05/14/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 80 YR