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

Model Number	26280
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was unable to be re-constrained.Target lesion was located in the iliac vein.A 12x90/8fr 75cm wallstent uni was advanced for treatment.However, it was found that the lesion could not be covered when one third of the stent was deployed.The physician withdrew the device, but the stent could not be fully withdrawn into the delivery system.The physician withdrew the stent from the patient's body but it was observed that it could not be withdrawn during the vitro examination.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was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 device was received with the stent partially deployed from the device.The investigator was unable to reconstrain the stent.The investigator successfully deployed the stent without issue.A microscopic examination found no damage or issues with the deployed stent.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.A visual and tactile examination found no damage or issues to the delivery system that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent was unable to be re-constrained.Target lesion was located in the iliac vein.A 12x90/8fr 75cm wallstent uni was advanced for treatment.However, it was found that the lesion could not be covered when one third of the stent was deployed.The physician withdrew the device, but the stent could not be fully withdrawn into the delivery system.The physician withdrew the stent from the patient's body but it was observed that it could not be withdrawn during the vitro examination.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was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: 10018333
• Report Number: 2134265-2020-05902
• Device Sequence Number: 2208734
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 09/08/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024395414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 56