MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, BALLOON TYPE

Catalog Number UNK_NEU

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

Patient Problems Hemorrhagic Stroke (4417); Ischemia Stroke (4418)

Event Date 08/09/2022

Event Type  Death  

Event Description

In a prospective, multicenter, randomized, open-label, outcome assessor¿blinded study conducted to determine the "effect of stenting plus medical therapy vs medical therapy alone on risk of stroke and death in patients with symptomatic intracranial stenosis" (the cassiss randomized clinical trial), out of 358 patients eligible, 176 patients underwent medical therapy with balloon angioplasty with subject balloon and stenting between 05 march 2014 to 10 nov 2016 and were followed up for 3 years.It was reported in this study that there were 3 deaths (related to stroke) within 3 yrs.1 death was due to hemorrhagic stroke within 30 days of enrollment where patient developed massive cerebral infarction and brain hernia either due to guidewire perforation or due to reperfusion.2 other deaths were due to ischemic stroke.No further information was available.Multiple devices were used in conjunction with the subject balloon and there was no definitive evidence in the article to conclude or deny that the adverse event was related to the subject device.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 3 events of death covered within this literature source.

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

In a prospective, multicenter, randomized, open-label, outcome assessor¿blinded study conducted to determine the "effect of stenting plus medical therapy vs medical therapy alone on risk of stroke and death in patients with symptomatic intracranial stenosis" (the cassiss randomized clinical trial), out of 358 patients eligible, 176 patients underwent medical therapy with balloon angioplasty with subject balloon and stenting between 05 march 2014 to 10 nov 2016 and were followed up for 3 years.It was reported in this study that there were 3 deaths (related to stroke) within 3 yrs.1 death was due to hemorrhagic stroke within 30 days of enrollment where patient developed massive cerebral infarction and brain hernia either due to guidewire perforation or due to reperfusion.2 other deaths were due to ischemic stroke.No further information was available.Multiple devices were used in conjunction with the subject balloon and there was no definitive evidence in the article to conclude or deny that the adverse event was related to the subject device.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 3 events of death 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.It cannot be confirmed if the device met specification, as the device was not returned.Stroke and death are listed in the ifu as adverse events associated with the use of intracranial angioplasty in stenotic lesions of the intracranial arteries.An assignable cause of anticipated procedural complication, will be assigned to the reported events of patient stroke and patient tia (transient ischemic attack), as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15507044
• MDR Text Key: 300861224
• Report Number: 3008853977-2022-00048
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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
• Date Manufacturer Received: 11/09/2022
• 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
• Treatment: WINGSPAN STENT SYSTEM (STRYKER).
• Patient Outcome(s): Other; Death