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	Extravasation (1842); Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
Date of Event	03/04/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Perforation and hemorrhage, are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that these reported adverse events were anticipated procedural complications.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2016-00547, 3005168196-2016-00548, 3005168196-2016-00549.The hospital disposed of the device.
Event or Problem Description
On (b)(6) 2013, the patient underwent a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 5max separator (sep5), a penumbra system 5max reperfusion catheter (5max), a velocity delivery microcatheter (velocity) and a penumbra system 4max separator (sep4).Prior to the procedure, the patient was given four units of fresh frozen plasma (ffp).On the final run, extravasation at the mca bifurcation was noted and so 50 mg of protamine was given to reverse heparin.The target vessel was recanalized; however, a vessel perforation was identified, which was related to the devices used.A follow-up dyna computerized tomography (ct) was performed and revealed a sylvian subarachnoid hemorrhage (sah) and intraventricular hemorrhage (ivh) in the fourth ventricle.About six hours later, a noncontrast computerized tomography (ncct) was performed and showed evidence of sah but the ivh was not visible anymore.On post-operative day 1 ((b)(6) 2013), an ncct was performed and still showed the sah.On post-operative day 2 ((b)(6) 2013), another ncct was performed and showed a slight hemorrhagic transformation in the right caudate nucleus and only slight residual subarachnoid hemorrhage.The patient remained in the intensive care unit (icu) on mechanical ventilation without evidence of neurological improvement.Following family wishes, a do not resuscitate (dnr) order was initiated and transition to comfort measures only.The patient was extubated and expired on (b)(6) 2013.The cause of death was reported to be terminal extubation and sick sinus syndrome post extubation.The sylvian sah was reviewed and adjudicated by the committee to be a non-serious adverse event that was possibly related to the penumbra system, possibly related to the procedure and not related to the index stroke.The sah was noted to be due to perforation and was unresolved at the time of death.The hemorrhagic transformation was reported as an adverse event but was not related to the penumbra system.

• Brand Name: PENUMBRA SYSTEM 4MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5615379
• Report Number: 3005168196-2016-00550
• Device Sequence Number: 13614788
• Product Code: NRY
• UDI-Device Identifier: 00814548010427
• UDI-Public: 00814548010427
• 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): 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 Catalogue Number: PSF041
• 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: 04/28/2016
• 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; Other; Required Intervention
• Patient Age: 85 YR