MAUDE Adverse Event Report: PENUMBRA, INC. 3D REVASCULARIZATION DEVICE; CATHETER THROMBUS RETRIEVER

Model Number	PSR3D-A
Health Effect - Clinical Codes	Death (1802); Occlusion (1984); Stenosis (2263); Respiratory Failure (2484)
Date of Event	07/23/2018
Type of Reportable Event	Death
Event or Problem Description
Pt's ct showed occlusion of the right m1 segment of the middle cerebral artery and atherosclerotic 80% stenosis left ica origin.Neurosurgery interventionalist was consulted.Pt intubated for airway management, and taken to or for thrombectomy.Cerebral angiogram was completed, however thrombectomy was unsuccessful.Right femoral access, right cca and ica angios showed right m1 occlusion deployed, device failed with separation at wire junction.Unable to retrieve deployed stent with snare attempts.Stent remained in pt.Unsuccessful thrombectomy, no change in flow.Physician operator did not use any unusual force, slow removal until felt tension released and the wire came out without the attached stent.Physician notified and spoke directly with mfr rep following the event.On (b)(6) 2018 pt intubated.Developed increasing signs of respiratory failure, inability to handle secretions.On (b)(6) 2018: family made pt comfort care, dnr (b)(6) 2018 at 1:15 am.Pt expired.

• Brand Name: 3D REVASCULARIZATION DEVICE
• Common Device Name: CATHETER THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC. ; alameda CA 94502
• MDR Report Key: 7746406
• Report Number: MW5078830
• Device Sequence Number: 16574035
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: (01)00814548017853(17)200816(10)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2018
• 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
• Patient Age: 85 YR
• Patient Weight: 73