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

Model Number	26280
Medical Device Problem Codes	Retraction Problem (1536); Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent reconstraining difficulties were encountered.The target lesion was located in the stenosed iliac vein.A 16x90/9fr uni plus 75cm wallstent endoprosthesis was selected for treatment.However, the stent deployment location was not in the correct location.When the physician attempted to reposition the stent, it could not be reconstrained despite being less than one third deployed.The stent was released and after the catheter was removed from the patient's body, the catheter was found to be twisted.The physician deployed another of the same device to the desired position and completed the procedure.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The stent was not returned for analysis as the stent had been deployed during the procedure.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified that the blue outer was bunched and twisted starting 120mm proximal from the distal end of the blue outer and extending 75mm proximally.This type of damage is consistent with a restriction being encountered and excessive tensile force being applied when attempting to deploy the stent.The stainless-steel tube was also noted to be kinked 78mm distal from hub.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent reconstraining difficulties were encountered.The target lesion was located in the stenosed iliac vein.A 16x90/9fr uni plus 75cm wallstent endoprosthesis was selected for treatment.However, the stent deployment location was not in the correct location.When the physician attempted to reposition the stent, it could not be reconstrained despite being less than one third deployed.The stent was released and after the catheter was removed from the patient's body, the catheter was found to be twisted.The physician deployed another of the same device to the desired position and completed the procedure.No patient complications were reported and the patient's status was stable.

• 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: 9337702
• Report Number: 2134265-2019-13975
• Device Sequence Number: 11250553
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 06/09/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023924423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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
• Patient Age: 49 YR
• Patient Weight: 65