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

Model Number 26280

Device Problems Mechanical Problem (1384); Material Deformation (2976); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that stent expansion, stent recapture difficulties and stent damaged were encountered.The target lesion was located in a deep vein thrombosis, a 18x40/10fr uni plus 75cm wallstent uni stent catheter was advanced to treat the lesion.The physician noticed that the stent did not fully open.The stet was attempted to be recontrained but it was not able to be reconstrained.The stent was implanted and it was noticed under angiography that the stent was kinked.Another stent was implanted to complete the procedure.No patient complications were reported and the patient 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: 8804562
• MDR Text Key: 151500423
• Report Number: 2134265-2019-08445
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729204060
• UDI-Public: 08714729204060
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021468388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• 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