MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX SEPARATOR; NRY

Catalog Number	PSF054
Medical Device Problem Codes	Flaked (1246); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Foreign Body In Patient (2687)
Date of Event	01/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2016-00186, 3005168196-2016-00187, 3005168196-2016-00189.The hospital disposed of the device.
Event or Problem Description
On (b)(6) 2015, the patient received tpa and underwent a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace), a penumbra system 3max reperfusion catheter (3max), a penumbra system 5max separator (sep5) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the patient suffered an intracranial hemorrhage and was anti-coagulated since the physician believed the patient's stroke was from hypercoagulability.In (b)(6) 2015, the patient had worsening of left-sided weakness and was found to have a right subdural hematoma (sdh), which was evacuated.The patient's warfarin was discontinued.On (b)(6) 2015, the patient returned with dizziness and worsened left sided weakness.In late (b)(6) 2015, the patient again had worsening of the left-sided weakness.A computed tomography (ct) of the patient's head was performed and revealed some right hemisphere edema.On (b)(6) 2015, a subsequent magnetic resonance imaging (mri) was performed, which showed marked increase in fluid-attenuated inversion recovery (flair) hyper-intensity in the right temporal, occipital and parietal lobes.On (b)(6) 2015, a follow-up brain mri was performed, which showed extensive scattered foci of contrast enhancement scattered throughout the right hemisphere and involving the leptomeninges of the right hemisphere.On (b)(6) 2016, the patient was admitted for a brain biopsy and was hospitalized with increasing headache and increasing weakness.On (b)(6) 2016, the brain biopsy was performed.The biopsy results showed necrotizing foreign body granulomatous inflammation secondary to endovascular polymer embolization.On (b)(6) 2016, the patient was taken to the operating room (or) for an open tumor biopsy in the right temporoparietal region.On (b)(6) 2016, the patient's biopsy results came in and revealed presence of areas of necrosis associated with a dense polymorphonuclear cell infiltrate surrounded by a histiocytic granulomatous reaction with presence of giant cells.In one of the granulomatous, filamentous granular pale blue foreign body material was identified consistent with fragments of catheter hydrophilic polymer coating.The inflammatory process appeared to involve the leptomeninges as well as the underlying brain parenchyma.Per the hospital staff's opinion, the presumed origin for the material would be the coating on the devices used for the patient's mechanical thrombectomy performed on (b)(6) 2015.
Event or Problem Description
Additional information provided by the customer: the thrombectomy procedure was a success and the patient did very well for a few months post treatment of the stroke.Another manufacturer's guidewire was also used for the procedure.Per the physician, it is unknown if the penumbra devices were contributory causes to the necrotizing foreign body in the patient and it is unknown what the cause of the necrotizing foreign body.As of (b)(6) 2016, the patient is doing better.

• Brand Name: PENUMBRA SYSTEM 5MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5445750
• Report Number: 3005168196-2016-00188
• Device Sequence Number: 397566
• Product Code: NRY
• UDI-Device Identifier: 00814548010434
• UDI-Public: 00814548010434
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: PSF054
• Device Lot Number: F47203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2016
• Supplement Report FDA Received Date: 03/30/2016
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 62