MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889)
Date of Event	02/11/2017
Type of Reportable Event	Death
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.Cerebral hemorrhage and death are potential adverse events with use of the penumbra system and are included in the device labeling.Therefore, it was determined that the reported cerebral hemorrhage and subsequent patient death were anticipated procedural complications.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was disposed of by the hospital.
Event or Problem Description
On (b)(6) 2017, the patient was underwent a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the physician completed one pass using a non-penumbra guiding catheter, a non-penumbra microcatheter, a 5max ace and a non-penumbra stent retriever device.The patient¿s thrombolysis in cerebral infarction (tici) score was iia.After removing the stent retriever device, the procedure was completed using a non-penumbra catheter and the patient¿s final thrombolysis in cerebral infarction (tici) score was iii.However, seven hours after the procedure, symptomatic intracranial hemorrhage was observed in the right middle cerebral artery (ph2 / phr2).The patient suffered from cerebral edema, consciousness disturbance, and respiratory disturbance, but it is not identified whether an additional treatment was performed or not.The patient expired on (b)(6) 2017 due to cerebral hemorrhage.The physician stated that it is unclear which device (penumbra¿s or the other manufactures¿) directly caused the reported cerebral hemorrhage and subsequent patient death because three different devices were used during the procedure.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7175729
• Report Number: 3005168196-2018-00082
• Device Sequence Number: 13756034
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2017

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 Expiration Date: 01/05/2019
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F67181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2017
• Initial Report FDA Received Date: 01/09/2018
• 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: Death; Life Threatening; Other
• Patient Age: 40 YR