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

Model Number 26280

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual and microscopic examination was performed on the returned wallstent device.No damage or any issues were identified with the tip that could have contributed to the complaint incident.A visual and tactile examination identified that the catheter shaft was kinked at various locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the catheter that could have contributed to the damage identified.The sheath was not retracted and was pushed right up to the tip.Using the t-bar handle the outer sheath was retracted back to expose where the stent should have been crimped.It was confirmed that the stent was deployed and was not returned.No issues were noted with the deployment functionality of the device.A visual and microscopic examination identified no damage or any issues with the stent cups or stent holder of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

Reportable based on additional information received on 02-jul-2019.It was reported that stent deployment failure occurred.The >75% stenosed target lesion was located in the axillary vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced but could not deploy in the patient's body.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and patient was stable.However, additional information confirmed that the stent was inadvertently deployed outside the patient's body.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8853476
• MDR Text Key: 153153313
• Report Number: 2134265-2019-09142
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022540451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 58