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

Catalog Number	PSR3D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/13/2018
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.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Hemorrhage is a known and anticipated complication with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).It was noted that the patient received tissue plasminogen activator (tpa) prior to being transferred to the hospital.During the procedure, while using the psr3d and a penumbra system jetd reperfusion catheter (jetd), the patient had multiple episodes of vomiting and the procedure ultimately had to be stopped without successful clot retrieval as the risk for aspiration became too high.The patient was then intubated and transferred to the intensive care unit (icu) for further care.Post procedure, a deterioration of neurological status was noted with a change in the national institutes of health (nih) stroke scale from 8 to 22.Additionally, a post procedure imaging revealed two areas of symptomatic intracranial hemorrhage (ich) likely related to both procedure and pre-procedure tpa.The symptomatic intracranial hemorrhage was reported to be a serious adverse with a possible relationship to the psr3d and definite relationship to the index procedure.

• 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: 8182818
• Report Number: 3005168196-2018-02462
• Device Sequence Number: 19229453
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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
• Report Date (Section B): 11/20/2018
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: C07670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005