MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occured.A 18x90mm wallstent endoprosthesis was selected for use for a stenting procedure in the left iliac vein.While the physician was attempting to deploy the stent, the stent collapsed on itself.The physician then had to use a 16x90mm wallstent endoprosthesis, however, the same issue began to occur when the physician attempted deployment.The stent was retracted and removed.Another 16x90mm wallstent endoprosthesis was then used to complete the procedure with no issues.There were no patient complications and the patient was fine post procedure.
Event or Problem Description
It was reported that stent damage occured.A 18x90mm wallstent endoprosthesis was selected for use for a stenting procedure in the left iliac vein.While the physician was attempting to deploy the stent, the stent collapsed on itself.The physician then had to use a 16x90mm wallstent endoprosthesis, however, the same issue began to occur when the physician attempted deployment.The stent was retracted and removed.Another 16x90mm wallstent endoprosthesis was then used to complete the procedure with no issues.There were no patient complications and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the delivery system was not returned for analysis.The stent was returned detached from the delivery system and inside the customer introducer sheath.During analysis the investigator removed the stent.Blood was noted on the stent.A visual and microscopic examination of the stent identified no damage or any issues that could have contributed to the complaint incident.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8379198
• Report Number: 2134265-2019-01866
• Device Sequence Number: 3057384
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 21910592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR