MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX SEPARATOR; NRY

Catalog Number	PSF041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death, Intrauterine Fetal (1855); Intracranial Hemorrhage (1891)
Date of Event	05/29/2015
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.Intracranial 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 intracranial 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.This report is associated with mfr report numbers: 3005168196-2016-01423, 3005168196-2016-01424, 3005168196-2016-01425.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure for a cardiogenic cerebral infarction in the left middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace), a penumbra system 5max separator (5max separator), a penumbra system 4max reperfusion catheter (4max) and a penumbra system 4max separator (4max separator).During the procedure, the physician attempted to aspirate the thrombus using the 5max ace and 5max separator but was unsuccessful because the thrombus was too stiff.Therefore, the physician decided to use another manufacturer's retrieval device to remove the thrombus; however, while using the retrieval device, the physician noticed that a piece of the thrombus migrated to the distal m2 segment of the mca.The physician then switched to the 4max and 4max separator to remove the thrombus in the m2 segment.The procedure was completed and the physician was able to remove all the thrombus from the patient.There were no alleged malfunctions with the penumbra devices.Following the procedure, the patient's thrombolysis in cerebral infarction (tici) grade improved from a zero to a three, indicating complete perfusion.However, within twenty-four hours after the procedure, symptomatic intracranial hemorrhage was confirmed in the segment where thrombus was removed.The physician then performed a craniotomy decompression to treat the intracranial hemorrhage; however, the patient expired on (b)(6) 2015 due to hemorrhagic cerebral infarction.The physician stated that it is unclear which devices (penumbra's or the other manufacturer's) caused the reported intracranial hemorrhage and subsequent patient death.However, he indicated that he could not rule out the possible relationship between the reported intracranial hemorrhage and patient's death to the penumbra devices because the cause of death was hemorrhagic cerebral infarction.

• Brand Name: PENUMBRA SYSTEM 4MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6011845
• Report Number: 3005168196-2016-01426
• Device Sequence Number: 40685
• Product Code: NRY
• UDI-Device Identifier: 00814548010427
• UDI-Public: 00814548010427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

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: 12/31/2016
• Device Catalogue Number: PSF041
• Device Lot Number: F40155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 10/07/2016
• 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: Death; Life Threatening; Required Intervention
• Patient Age: 69 YR