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 Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Event date: the exact date of the adverse event is unknown.All patients were treated between (b)(6) 2013 to (b)(6) 2015.The device is not available to the manufacturer.

Event Description

It was reported in the literature article that 6 patients out of 141 treated for symptomatic intracranial atherosclerotic stenosis with balloon (subject device) angioplasty and stent placement across the target lesion suffered tia or stroke within 30 days post procedure.It was impossible to determine what adverse event each patient had.No further details provided.

Manufacturer Narrative

The device was not available for analysis.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Stroke and transient ischemic attack (tia) are known and anticipated complications to these types of procedures and are noted in the labeling.Therefore, it was determined that the reported event was an anticipated patient complication.

Event Description

It was reported in the literature article that 6 patients out of 141 treated for symptomatic intracranial atherosclerotic stenosis with balloon (subject device) angioplasty and stent placement across the target lesion suffered tia or stroke within 30 days post procedure.It was impossible to determine what adverse event each patient had.No further details provided.

• 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5161923
• MDR Text Key: 28793346
• Report Number: 3008853977-2015-00429
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• 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