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	Death (1802); Ischemia (1942); Neurological Deficit/Dysfunction (1982)
Date of Event	02/06/2014
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.Death and neurological deficits including stroke are known complications with these types of procedures and are noted in the device labeling.This report is associated with mfr report numbers: 3005168196-2016-00429; 3005168196-2016-00430.The hospital disposed of the device.
Event or Problem Description
On (b)(6) 2014, the patient was taken in for intravascular intervention.Arterial puncture was done at 11:47 hours and angiogram demonstrated left m1 occlusion (tici 0).The patient underwent a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace), a penumbra system 3max reperfusion catheter (3max) and a penumbra system 3max separator (sep3).No procedural complications were reported; however, in the following days after the procedure, the patient's health status deteriorated and the patient remained paretic on the right side and became unresponsive.While the patient was intubated on (b)(6) 2014, her national institutes of health stroke scale (nihss) increased from 20 to 27.After a meeting, the patient's family decided to make the patient a dnr (do not resuscitate) and to withdraw care; therefore, the patient was extubated and maintained on a morphine drip for comfort until she expired on (b)(6) 2014.The patient's progression of stroke was reported as a serious adverse effect (sae) and a cause of death.The committee adjudicated this sae to have a definite relationship to the index stoke and an uncertain relationship to the penumbra system and the angiographic procedure.

• Brand Name: PENUMBRA SYSTEM 3MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5528357
• Report Number: 3005168196-2016-00431
• Device Sequence Number: 146204
• 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: 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): 02/26/2016

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: 08/31/2016
• Device Catalogue Number: 3MAXS
• Device Lot Number: F37598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2016
• Initial Report FDA Received Date: 03/27/2016
• 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; Other
• Patient Age: 84 YR