MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX SEPARATOR; NRY

Catalog Number	3MAXS
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	07/03/2014
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.Hemorrhage, is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported hemorrhage with perforation was an anticipated procedural 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: 3005168196-2016-00574, 3005168196-2016-00575.The device was disposed of by the hospital.
Event or Problem Description
On (b)(6) 2014, the patient underwent a thrombectomy procedure using a penumbra system 3max reperfusion catheter and two penumbra system 3max separators.The procedure was completed without any complications.However, on day 1 (post - operation on (b)(6) 2014), brain imaging revealed evidence of an intracerebral hemorrhage (ich).The ich was reported as a non-serious adverse termed 'hemorrhagic transformation' and was determined to be possibly related to the penumbra system and the procedure, and definitely related to the index stroke.The reported pattern of hemorrhage also suggests the possibility of vessel perforation.Patient follow-up: on post-operation day 7 ((b)(6) 2014), the patient was transferred to a hospice care and expired on (b)(6) 2014.Progression of the index stroke was reported as the cause of death.

• Brand Name: PENUMBRA SYSTEM 3MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5621315
• Report Number: 3005168196-2016-00573
• Device Sequence Number: 16232293
• Product Code: NRY
• UDI-Device Identifier: 00814548012483
• UDI-Public: 00814548012483
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113163
• 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: 11/30/2016
• Device Catalogue Number: 3MAXS
• Device Lot Number: F39485
• 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: Other
• Patient Age: 84 YR