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

Model Number H965SCH647070

Device Problems Bent (1059); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

It was reported that difficulty withdrawing a stent and stent damage occurred.During an angioplasty, the physician had difficulty withdrawing the 8.0-21 carotid wallstent¿.After several attempts, the physician was able to withdraw the stent delivery system (sds).The physician noticed that there was damage to the stent.The procedure was completed with a different device.There were no patient complications and the patient's condition is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device found that the outer sheath had been retracted and the stent had been deployed.The stent was not returned.No issues were noted with the profile of the stent holder or inner.It was noted that the white shrink tubing had detached from the valve body and kinking of the outer sheath was noted distal to the white shrink tubing.However it was possible to move the outer sheath distally and proximally along the shaft with a slight resistance noted due to kinking of outer sheath.No other issues were noted.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 difficulty withdrawing a stent and stent damage occurred.During an angioplasty, the physician had difficulty withdrawing the 8.0-21 carotid wallstent.After several attempts, the physician was able to withdraw the stent delivery system (sds).The physician noticed that there was damage to the stent.The procedure was completed with a different device.There were no patient complications and the patient's condition is stable.

• Brand Name: CAROTID WALLSTENT?
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4157390
• MDR Text Key: 4868563
• Report Number: 2134265-2014-06330
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2017
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Device Lot Number: 16848969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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 Age: 76 YR