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 Problem Vascular Dissection (3160)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

Event date: the exact date of the adverse event is unknown.All patients were treated between january 2013 to june 2015.Complaint #15: this is 15 of 19 reports for this article (including mfr# 3008881809-2016-00331 has been redacted after further review of the literature article).A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, vessel dissection is a known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.This current report represents the initial and final report for this event.The original initial report number ¿0002134265-2016-00037¿ for this event should be deleted from the emdr system.The information contained within this report represents information contained in the original report number listed above and any supplemental information gathered that was not previously provided to fda.The information in this current report was not provided as a supplemental report to the original report number listed above because the original initial mdr report number may now considered a duplicate report number by fda¿s emdr system.The subject device is not available.

Event Description

The article presented retrospective evaluation of experience for one-single site of the factors affecting the risk of perforator stroke after basilar artery angioplasty and/or stenting.A total of 255 patients were included in the study, and the decision to perform endovascular treatment as well as the stent type were made based on arterial access and lesion morphology.For those with tortuous access and mori b or c lesions or if the diameters of the proximal and distal segments were significantly different, angioplasty plus a self-expanding stent (balloon plus stent system) was preferred.For patients with tortuous arterial access with a mori a lesion or a small target vessel diameter (<2.5 mm), angioplasty alone with a balloon was selected.Procedure-related perforator stroke was identified in 13 patients (5.1%).Except for perforator stroke some patients had some other complications.Approx 6 patients suffered from vessel dissection after subject balloon expansion.No further information is available.

• 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: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6531963
• MDR Text Key: 74007984
• Report Number: 0002134265-2017-30024
• 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
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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?: Yes
• Date Manufacturer Received: 12/07/2016
• 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