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

Model Number	26280
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was aborted.The patient presented with iliac vein compression syndrome.The 85% stenosed target lesion was located in the non-calcified and moderately tortuous iliac vein.A 14x60/9fr wallstent endoprosthesis was advanced for treatment, but it was found that the stent was not positioned accurately inside the patient for the first time.When the physician recaptured and re-deployed it, the stent could not be fully deployed.The stent was reconstrained prior removal of the device.The procedure was aborted and will be done at a later date.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a wallstent uni plus device was received for analysis.The stent was returned in the correct position on the delivery system.The investigator successfully deployed the stent with any issues.A visual examination identified no issues or damage to the deployed stent.A visual 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 found no issues with the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that the procedure was aborted.The patient presented with iliac vein compression syndrome.The 85% stenosed target lesion was located in the non-calcified and moderately tortuous iliac vein.A 14x60/9fr wallstent endoprosthesis was advanced for treatment, but it was found that the stent was not positioned accurately inside the patient for the first time.When the physician recaptured and re-deployed it, the stent could not be fully deployed.The stent was reconstrained prior removal of the device.The procedure was aborted and will be done at a later date.There were no patient complications reported and the patient 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16252825
• Report Number: 2124215-2023-01419
• Device Sequence Number: 5350603
• Product Code: MAF
• UDI-Device Identifier: 08714729204008
• UDI-Public: 08714729204008
• 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): 02/27/2023

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: 01/18/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026651528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 83 KG