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

Model Number 26280

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

Event Type  Injury  

Event Description

It was reported that stent migration occurred.The target lesion was located in the iliac vein.A 12x40/8fr/75cm wallstent endoprosthesis stent was advanced for treatment.However, there was difficulty in deploying the stent and when the stent was eventually deployed, the stent moved away from the lesion.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
• 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: 8826687
• MDR Text Key: 152199359
• Report Number: 2134265-2019-08720
• Device Sequence Number: 1
• Product Code: MIR
• UDI-Device Identifier: 08714729203957
• UDI-Public: 08714729203957
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021847445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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 Outcome(s): Required Intervention