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

Catalog Number	PSR3D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	02/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Results: the penumbra system 3d revascularization device (psr3d) stent was fractured from the delivery wire and tangled in the non-penumbra stent retriever.The psr3d stent detached via double strut fracture at the detached tip.The psr3d was damaged and unable to be functionally tested.The psr3d stent portion was untangled from the stent retriever during investigation.Conclusions: evaluation of the returned psr3d revealed that the stent portion was fractured from the delivery wire via a double strut fracture.This damage is likely a result of forcefully retracting the device against resistance.Further evaluation revealed that the stent was damaged.This damage was likely a result of the retrieval process using the non-penumbra stent retriever.Penumbra psr3ds are inspected during in-process inspection and during quality inspection after manufacturing.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 middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician did not mention any resistance while using the psr3d.However, the psr3d stent fractured from the pusher wire on the first pass.Therefore, the physician used another stent retriever to remove the psr3d with the thrombus attached.After the stent retriever and psr3d were removed, an angiography was performed and revealed that the mca had become perforated.However, it is unknown when the perforation occurred and which device caused the perforation.The physician then used coils (unknown manufacturer) to treat the perforation.The patient's current medical status is unknown.
Event or Problem Description
On may 10th, 2018 additional information was received indicating that the patient expired.The cause of death is unknown and the relationship between the patient's death and the psr3d is unknown.

• 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: 7311753
• Report Number: 3005168196-2018-00482
• Device Sequence Number: 11331292
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/03/2018
• 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: Physician
• Device Expiration Date: 09/05/2020
• Device Catalogue Number: PSR3D
• Device Lot Number: F79404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/03/2018
• Supplement Date Received by Manufacturer: 05/10/2018; 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 03/15/2019; 09/09/2019; 09/13/2019
• 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: 84 YR
• Date Report Sent to FDA: 01/01/2005