MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

Model Number	PSR3D-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/23/2018
Type of Reportable Event	Death
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician placed a penumbra system ace 68 reperfusion catheter (ace68) in the target vessel, then advanced the psr3d through a velocity delivery microcatheter (velocity).However, the thrombectomy was unsuccessful.While attempting to pull the psr3d into the ace68, the physician experienced resistance and subsequently, the psr3d broke off from its delivery wire.The physician attempted to remove the detached piece of the psr3d using a snare device; however, it was unsuccessful.Therefore, the psr3d was left in the m1 segment of the mca.It was reported that there was no noted damage to the ace68 and the velocity.The patient was intubated and developed increasing signs of respiratory failure, and inability to handle secretions.The patient¿s family made patient comfort care and do not resuscitate.The patient expired from complications due to stroke in the hospice care.The physician was unable to confirm the relationship between the patient¿s cause of death and the psr3d.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7807570
• Report Number: 3005168196-2018-01667
• Device Sequence Number: 1052705
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• 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): 07/24/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: PSR3D-A
• Device Catalogue Number: PSR3D
• Device Lot Number: F78719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 06/12/2020
• 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
• Date Report Sent to FDA: 01/01/2005