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); Neurological Deficit/Dysfunction (1982)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) could not be reviewed because the batch remains unknown.However, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, patient stroke and complications are known risk associated with endovascular procedures and are noted as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.This current report represents the initial and final report for this event.The original initial report number ¿0002134265-2016-00028¿ for this event should be deleted from the emdr system.The original initial mdr report number may now considered a duplicate report number by fda¿s emdr system.However, the information contained within this report represents the corrected information to the initial report and supplemental report.Redaction, thus the reason for this report: additional information received from the study facility indicated that the patient did not any new stroke and the neurological deficit was due to the presenting index stroke.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that following angioplasty with balloon catheter, a stent (subject device) was placed across the atherosclerotic lesion.The next day, the patient developed a stroke with neurological deficit.Medication (not specified) was administered to treat the stroke.Two days post procedure, the patient was discharged to rehabilitation center with modified rankin scale (mrs) of 3.The physician believed that the event was related to pre-existing condition but relationship to the procedure and devices unknown.However, the next day patient experienced fall and seizure and patient¿s hospital stay was prolonged.This event was resolved without residual effects.

• 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: 6595599
• MDR Text Key: 76123825
• Report Number: 0002134265-2017-30033
• Device Sequence Number: 1
• Product Code: GBA
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• 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: 04/28/2017
• 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
• Patient Age: 71 YR