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

Model Number	26280
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent damage occurred.A 16x40/9fr uni plus 75cm wallstent endoprosthesis was selected for use.However, resistance was observed during deployment and the weave was damaged after implantation.Subsequently, another wallstent was used to overlap the first deployed stent.There were no patient complications reported.The procedure was completed and the patient status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Bsc aware date corrected from 06/23/2020 to 06/19/2020 for initial report.
Event or Problem Description
It was reported that stent damage occurred.A 16x40/9fr uni plus 75cm wallstent endoprosthesis was selected for use.However, resistance was observed during deployment and the weave was damaged after implantation.Subsequently, another wallstent was used to overlap the first deployed stent.There were no patient complications reported.The procedure was completed and the patient status was stable.It was further reported that the target lesion had 94% stenosis which was located in a moderately tortuous and non-calcified vessel.The stent struts were damaged post-implantation.

• 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: 10212168
• Report Number: 2134265-2020-08672
• Device Sequence Number: 2120814
• Product Code: MAF
• UDI-Device Identifier: 08714729204039
• UDI-Public: 08714729204039
• 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
• Report Date (Section B): 07/06/2020

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: 07/30/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024194082
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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