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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a stent partially deployed and was damaged after it was implanted.A 14mm x 90mmx 75cm, 9french wallstent uni self expanding stent was selected to treat 75% stenosis in the iliac vein.The stent was advanced along the guidewire to the lesion and it was positioned accurately in the lesion.During deployment, the stent partially deployed.It could not deploy and could not be withdrawn.The physician pulled out the delivery shaft to deploy stent.The stent was severely elongated and deformed inside the patient's body.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device eval by mfr: the device was received and analysis was completed.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned for analysis.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 a shaft kink located approximately 265mm distal from the distal end of the t connector.
Event or Problem Description
It was reported that a stent partially deployed and was damaged after it was implanted.A 14mm x 90mmx 75cm, 9french wallstent uni self expanding stent was selected to treat 75% stenosis in the iliac vein.The stent was advanced along the guidewire to the lesion and it was positioned accurately in the lesion.During deployment, the stent partially deployed.It could not deploy and could not be withdrawn.The physician pulled out the delivery shaft to deploy stent.The stent was severely elongated and deformed inside the patient's body.The procedure was completed with a different device.There were no patient complications reported.The device was received and analysis was completed on 25jan2022.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned for analysis.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 a shaft kink located approximately 265mm distal from the distal end of the t connector.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13068279
• Report Number: 2134265-2021-16164
• Device Sequence Number: 19872124
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 12/21/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026551115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 77 KG