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 (b)(6) 2013 to (b)(6) 2015.Complaint #15: it was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.Therefore, this reported addresses all patients under vessel dissection after subject balloon expansion within this literature source this is 15 of 18 reports for this article.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 (subject 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 subject balloon was selected.Procedure-related perforator stroke was identified in 13 patients (5.1%).Except for perforator stroke some patients had some other complications.¿6 patients suffered from vessel dissection after subject balloon expansion.If severe dissection or elastic recoil occurred after dilation, a balloon-mounted stent (for lesions with less tortuous access) or stent (for lesions with severe tortuous access or small target vessel) could be implanted.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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6200675
• MDR Text Key: 63181579
• Report Number: 0002134265-2016-00037
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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