MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM; STENT, CORONARY

Model Number UNK679

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as mdr id#: 2134265-2018-02312.It was reported that the stent foreshortening occurred.The target lesion was located in the left iliac vein.A 18x60 mm wallstent® endoprosthesis stent was implanted for treatment.However, the stent was noted to be shortened and had to place additional 18x40 wallstent® endoprosthesis stent.The stent was successfully deployed; however, upon removal of the delivery system, resistance was encountered.The delivery system hung up on the sheath at the distal marker.The device was advanced further into the inferior vena cava and back through the sheath.During this time, the delivery system became stuck at the proximal marker.Eventually, the sheath and the delivery system was removed as a unit and the procedure was completed.No patient complications were reported and the patient was not negatively affected.

• Brand Name: WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7384987
• MDR Text Key: 103940076
• Report Number: 2134265-2018-02331
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• 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): Required Intervention