MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Catalog Number	THNDRRED68KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasoconstriction (2126); Visual Impairment (2138); Ischemia Stroke (4418)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the mca using a penumbra system red 68 reperfusion catheter (red 68).After completion of the first pass, a severe vasospasm of m1 segment was noted.The physician then administered 600 mg nitroglycerin intraarterially to treat the vasospasm.It was reported that the vessel reoccluded after administering nitroglycerin with in-site thrombosis.Red68 was again used to perform thrombectomy.Subsequently, the vasospasm resolved with a clinical sequelae.Post procedure tici score of 7ici2c was achieved.After recovery, a follow-up mri conducted 5 hours post procedure showed re-occlusion of the left m1 segment and a large mca infarct.Right homonymous hemianopsia was also reported.Vasospasm and stroke were reported to be serious adverse events with a possible relationship to the index stroke, the index procedure, and the penumbra system.Right homonymous hemianopsia was reported to be a non-serious adverse event with a possible relationship to the penumbra system, the index stroke, and a probable relationship to the index procedure.As of (b)(6) 2022 the event is ongoing.
Additional Manufacturer Narrative
Vessel spasm, ischemia, neurological deficits including stroke are included as possible complications in the instructions for use (ifu) for the penumbra system reperfusion catheter 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.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 11/15/2022: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the mca using a penumbra system red 68 reperfusion catheter (red 68).After completion of the first pass, a severe vasospasm of m1 segment was noted.The physician then administered 600 mg nitroglycerin intraarterially to treat the vasospasm.It was reported that the vessel reoccluded after administering nitroglycerin with in-site thrombosis.Red68 was again used to perform thrombectomy.Subsequently, the vasospasm resolved with a clinical sequelae.Post procedure tici score of 7ici2c was achieved.After recovery, a follow-up mri conducted 5 hours post procedure showed re-occlusion of the left m1 segment and a large mca infarct.Right homonymous hemianopsia was also reported.Vasospasm and new left mca stroke were reported to be serious adverse events with a possible relationship to the index stroke, the index procedure, and the penumbra system.Right homonymous hemianopsia was reported to be a non-serious adverse event with a possible relationship to the penumbra system, the index stroke, and a probable relationship to the index procedure.As of (b)(6) 2022, the patient showed right homonymous hemianopsia with brain edema secondary to large stroke treated with hemicraniectomy.On (b)(6) 2022, patient continued to show increase edema with entrapment of left lateral ventricle.On (b)(6) 2022, the patient was discharged to inpatient rehabilitation.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2022-00529 1.Section g.Box 3.Report source.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the mca using a penumbra system red 68 reperfusion catheter (red 68).After completion of the first pass, a severe vasospasm of m1 segment was noted.The physician then administered 600 mg nitroglycerin intraarterially to treat the vasospasm.It was reported that the vessel reoccluded after administering nitroglycerin with in-site thrombosis.Red68 was again used to perform thrombectomy.Subsequently, the vasospasm resolved with a clinical sequelae.Post procedure tici score of 7ici2c was achieved.After recovery, a follow-up mri conducted 5 hours post procedure showed re-occlusion of the left m1 segment and a large mca infarct.Right homonymous hemianopsia was also reported.Vasospasm and new left mca stroke were reported to be serious adverse events with a possible relationship to the index stroke, the index procedure, and the penumbra system.Right homonymous hemianopsia was reported to be a non-serious adverse event with a possible relationship to the penumbra system, the index stroke, and a probable relationship to the index procedure.As of 21 oct 22, the patient showed right homonymous hemianopsia with brain edema secondary to large stroke treated with hemicraniectomy.On 24 oct 22, patient continued to show increased edema with entrapment of left lateral ventricle.On 02 nov 22, the patient was discharged to inpatient rehabilitation.On 13 jan-2023, we received an update from the clinical events committee (cec) that the final stroke size possibly increased by early re-occlusion of m1, and the intra-procedural vasospasm likely caused the early re-occlusion.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra clinical team on 01/13/2023: 1.Section b.Box 5.Describe event or problem h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15795057
• Report Number: 3005168196-2022-00529
• Device Sequence Number: 3101208
• Product Code: NRY
• UDI-Device Identifier: 00815948024373
• UDI-Public: 815948024373
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/09/2023
• 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: 06/08/2025
• Device Catalogue Number: THNDRRED68KIT
• Device Lot Number: F00001323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 01/14/2005; 01/13/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/09/2023; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005