MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT-UNI¿ ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M001731570

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that shaft break occurred.The target lesion was located in a moderately tortuous and moderately calcified coronary vessel.An 18 x 60mm x 75cm wallstent-uni¿ endoprosthesis was advanced to treat the lesion.However, during push and pull maneuvering of the device, the shaft broke.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the stent delivery system was returned for analysis.There were multiple kinks along the length of the outer.The most notable and badly kinked area of the device was the inner at the distal markerband area of the device.This damage is consistent with the application of excessive force.The stent was not returned with the device.The markerbands were visually and microscopically reviewed and no issues were identified.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 shaft break occurred.The target lesion was located in a moderately tortuous and moderately calcified coronary vessel.An 18 x 60mm x 75cm wallstent-uni endoprosthesis was advanced to treat the lesion.However, during push and pull maneuvering of the device, the shaft broke.No patient complications were reported and the patient's status was stable.

• Brand Name: WALLSTENT-UNI¿ ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 5393447
• MDR Text Key: 36951223
• Report Number: 2134265-2016-00066
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K992510
• 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: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2016
• Device Model Number: M001731570
• Device Catalogue Number: 73-157
• Device Lot Number: 0016822735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• 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