MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 05/15/2022

Event Type  Injury  

Event Description

It was reported in a literature article that of the 126 patients with symptomatic intracranial atherosclerotic disease with failed medical management who underwent intracranial stenting with subject wingspan stent system, 2 patients had hemorrhagic stroke (not resulting in death) and 2 patients had ischemic stroke (1 due to vasospasm after procedure, and 1 due to an in stent thrombus which was treated with intra arterial thrombolysis) within 72 hours post procedure.Beyond 72 hours, during angiographic and clinical follow up, 9 patients had stroke and 23 patients tia.During 6 month angiographic follow ups, 40 patients experienced in-stent restenosis of more than 50% stenosis of which 27 were symptomatic (23 of them needed retreatment by angioplasty) and 13 were asymptomatic.4 patients had less than 50% restenosis, 2 of whom were symptomatic but were left untreated.No further information is available.There is no definitive evidence in the article to conclude or deny that the adverse events were related to the subject devices.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints, if any.Therefore, this report addresses all events of stroke (not resulting in death), transient ischemic attack (tia) and in-stent restenosis covered within this literature source.

Manufacturer Narrative

The device remains implanted in the patient.

Event Description

It was reported in a literature article that of the 126 patients with symptomatic intracranial atherosclerotic disease with failed medical management who underwent intracranial stenting with subject wingspan stent system, 2 patients had hemorrhagic stroke (not resulting in death) and 2 patients had ischemic stroke (1 due to vasospasm after procedure, and 1 due to an in stent thrombus which was treated with intra arterial thrombolysis) within 72 hours post procedure.Beyond 72 hours, during angiographic and clinical follow up, 9 patients had stroke and 23 patients tia.During 6 month angiographic follow ups, 40 patients experienced in-stent restenosis of more than 50% stenosis of which 27 were symptomatic (23 of them needed retreatment by angioplasty) and 13 were asymptomatic.4 patients had less than 50% restenosis, 2 of whom were symptomatic but were left untreated.No further information is available.There is no definitive evidence in the article to conclude or deny that the adverse events were related to the subject devices.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints, if any.Therefore, this report addresses all events of stroke (not resulting in death), transient ischemic attack (tia) and in-stent restenosis covered within this literature source.

Manufacturer Narrative

Although the device history record (dhr) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.The reported event is covered in the device directions for use (dfu).This complaint was reported as part of a retrospective study conducted to determine the effectiveness of resolute onyx over wingspan stent system at preventing procedural complications and long term restenosis.The reported events of patient stroke, tia (transient ischemic attack), patient vessel restenosis, patient vasospasm serious and patient vessel thrombosis are documented in the wingspan dfu as observed/ anticipated adverse events.The issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.Based on an analysis of all available information, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15164321
• MDR Text Key: 297239096
• Report Number: 3008881809-2022-00383
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention