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, Cerebral (1889); Perforation of Vessels (2135)
Date of Event	02/15/2016
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 a device malfunction.Perforation and hemorrhage are known and anticipated complications with these types of procedures and are noted in the device labeling.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 5max separator (sep5).During the procedure, the physician first attempted to use the adapt technique (a direct aspiration, first pass technique), followed by another manufacturer's device and then finally used the sep5.The physician reported that the sep5 perforated the patient's middle cerebral artery (mca) and created a bleed.Another manufacturer's guidewire was also used for the procedure; however, the physician does not attribute the perforation to the guidewire.The bleeding resolved and the patient has had a second stroke unrelated to the perforation.The patient's health status at the time was poor due to the two strokes and not due to the sep5.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reported bleeding resolved spontaneously.The physician treated the second stroke (m2 occlusion) with the penumbra system ace 64 reperfusion catheter (ace 64); however, it did not work.He then tried treating the stroke with another manufacturer's device but that did not work either.After the two failed attempts to treat the second stroke with the ace 64 and the other manufacturer's device, the physician aborted treatment as he did not want to be aggressive.There was no device malfunction with the ace 64.The second stroke was unrelated to the first stroke and the bleeding.

• Brand Name: PENUMBRA SYSTEM 5MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5562883
• Report Number: 3005168196-2016-00450
• Device Sequence Number: 494135
• Product Code: NRY
• UDI-Device Identifier: 00814548010434
• UDI-Public: 00814548010434
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2016

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: 01/31/2017
• Device Catalogue Number: PSF054
• Device Lot Number: F40844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 05/10/2016
• 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
• Patient Age: 63 YR