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 Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that stent damage post-deployment occurred.The target lesion was located in the iliac vein.A 75 cm, 14x60/9fr wallstent endoprosthesis stent was placed.After using a 14mm balloon catheter for post-dilatation, the distal end of the stent was deformed.The procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that stent damage post-deployment occurred.The target lesion was located in the iliac vein.A 75 cm, 14x60/9fr wallstent endoprosthesis stent was placed.After using a 14mm balloon catheter for post-dilatation, the distal end of the stent was deformed.The procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.It was further reported that the procedure was completed with the original device and no additional stent was used in the procedure.
Event or Problem Description
It was reported that stent damage post-deployment occurred.The target lesion was located in the iliac vein.A 75 cm, 14x60/9fr wallstent endoprosthesis was selected for a procedure.The distal end of the stent was deformed after using a 14mm balloon catheter for post dilatation.The procedure was completed with the original device.No patient complications reported and the patient's status was stable.It was further reported that the procedure was completed with the original device and no additional stent was used in the procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Initial reporter address 1: (b)(6).Type of reportable event corrected to malfunction based on additional information received.Device evaluated by mfr.: the device as not returned for analysis, however media was provided.The returned cine images confirmed stent deformation was observed at the edge of the implanted stent.

• 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: 10296400
• Report Number: 2134265-2020-09272
• Device Sequence Number: 14074759
• Product Code: MAF
• UDI-Device Identifier: 08714729204008
• UDI-Public: 08714729204008
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024173483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 08/06/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention