MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX SEPARATOR; NRY

Catalog Number	PSF054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
Date of Event	05/13/2013
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.Perforation and hemorrhage, are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that these reported adverse events were anticipated procedural complications.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: 3005168196-2016-00556, 3005168196-2016-00558, 3005168196-2016-00559.The hospital disposed of the device.
Event or Problem Description
The patient underwent a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 5max reperfusion catheter, a penumbra system 5max separator, a penumbra system 3max reperfusion catheter and a penumbra system 3max separator.During the procedure, there was suspicion of tiny vessel perforation in left m3 segment - distant from the site of device placement; however, angiogram was unable to clearly confirm this.The final runs showed that the vessel was recanalized and also showed a vasospasm.At 14:25 hours, a follow up computerized tomography (ct) was performed and showed a circumscribed subarachnoid hemorrhage (sah) at the left insula.On postoperative day 1, another ct was performed and revealed that the sah had nearly completely resolved and only tiny spots of sah was seen in left dorsal insula.On (b)(6) 2013, the patient was discharged to a rehabilitation center.On (b)(6) 2013, the patient was seen again for a follow up visit and examination showed neurological and functional improvement.The reported vasospasm was reviewed and adjudicated by the committee to be a non-serious adverse event that was definitely related to the angiographic procedure, and unrelated to the penumbra system and the index stroke.The reported small sah was reviewed and adjudicated by the committee to be a non-serious adverse event that was related to the angiographic procedure and the penumbra system.The hemorrhage was noted to be due to perforation above the m3 branch.

• Brand Name: PENUMBRA SYSTEM 5MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5619661
• Report Number: 3005168196-2016-00557
• Device Sequence Number: 10825623
• Product Code: NRY
• UDI-Device Identifier: 00814548010434
• UDI-Public: 00814548010434
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2016

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: 08/31/2015
• Device Catalogue Number: PSF054
• Device Lot Number: F29443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2016
• Initial Report FDA Received Date: 04/29/2016
• 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: Life Threatening; Other
• Patient Age: 64 YR