MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT¿; STENT, CAROTID

Model Number H7493915010310

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that tip detachment and catheter removal difficulties were encountered.The target lesion was located in the right internal carotid artery (ic).A 10.0-31 carotid wallstent¿ stent was deployed to treat the lesion.However, removal of stent delivery system (sds) was attempted but failed.Attempts were made by covering the outer and stretching the carotid to change the course of vessel.Eventually, the sds was able to be removed, but the fluoroscopic image showed that the marker of stent had detached.Additional carotid wallstent was then used to trap the detached marker with the previously implanted stent and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: both carotid wallstent devices used in the procedure were returned.The stent holder was detached from one of the returned devices.The detached stent holder was not returned for analysis.It was reported that the component detached in the patient and was subsequently trapped in position by the second carotid wallstent device that was used in the procedure.The stent holder is glue bonded to the inner and is 100% inspected to ensure it is both bonded and dimensionally correct.The stent holder impression was evident on the returned device proving it was bonded to the device.The proximal outer was kinked 600mm from base of valve body on both returned devices.The middle outer was kinked 180mm from the proximal stent outer markerband on both returned devices.This damage is consistent with excessive force being applied to the delivery system during device use.The inner shaft was visually inspected on the device that was missing the stent holder and no issues were noted that may have led to the stent holder detaching from the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that tip detachment and catheter removal difficulties were encountered.The target lesion was located in the right internal carotid artery (ic).A 10.0-31 carotid wallstent stent was deployed to treat the lesion.However, removal of stent delivery system (sds) was attempted but failed.Attempts were made by covering the outer and stretching the carotid to change the course of vessel.Eventually, the sds was able to be removed, but the fluoroscopic image showed that the marker of stent had detached.Additional carotid walllstent was then used to trap the detached marker with the previously implanted stent and the procedure was completed.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5803882
• MDR Text Key: 49858891
• Report Number: 2134265-2016-06289
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: H7493915010310
• Device Catalogue Number: 39150-1031
• Device Lot Number: 18820158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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): Required Intervention