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

Catalog Number	PSR3D
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Vasospasm is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.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 number: 3005168196-2019-00626.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the carotid t segment using penumbra system 3d revascularization device (psr3d) and penumbra system jet 7 reperfusion catheter (jet7).During the procedure, the physician experienced intra-procedural vasospasm using the psr3d; therefore, the physician injected 100 mcg of intra-arterial nitroglycerin into the left internal carotid artery (ica) for treatment of the stent induced left middle cerebral artery (mca) vasospasm which resulted in resolution of the vasospasm.It was reported that resistance was encountered while pulling back the psr3d from the left middle cerebral artery (mca).This event was considered resolved on (b)(6) 2019.The intra-procedural vasospasm was adjudicated to be an adverse event with a possible relationship to the jet7, psr3d and a 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: 8487434
• Report Number: 3005168196-2019-00627
• Device Sequence Number: 2758657
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 03/06/2019
• 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: 06/07/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F83921
• 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: 03/06/2019
• Initial Report FDA Received Date: 04/05/2019
• 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: Required Intervention
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005