MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS WI; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Model Number 26280

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that stent foreshortening occurred.The target lesion was located in the left common iliac vein.A 16x90/9fr wallstent uni stent was advanced to the lesion and deployed.However, the distal end of the stent was rapidly shortened by about 3cm, and another 16x90/9fr wallstent uni stent was needed.During procedure, the vessel changed shape after the stent was placed.The second stent was unable to be advanced as the sheath was too large for the vessel.The physician gave up connecting the stent for safety reason and removed the stent.The procedure was cancelled.No patient complications were reported and the patient was stable.

Event Description

It was reported that profile problem was encountered.The target lesion was located in the left comon iliac vein.A 16x90/9fr wallstent uni stent was advanced but the distal end of the stent was rapidly shortened by about 3cm, and another 16x90/9fr wallstent uni stent was needed.During procedure, the vessel changed shape after the stent was placed because the sheath was too hard, and the second stent could not be advanced.The physician gave up connecting the stent for safety reason and removed the stent.No patient complications were reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination found that the stent of the device had been deployed.The stent was not returned for analysis as it was implanted inside the patient.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.No other issues were identified during the product analysis.

Manufacturer Narrative

(d4) model number, lot number, catalog number, expiration date, and unique identifier (udi) # updated to unknown.(h4) device manufacture date - unknown.

Event Description

It was reported that profile problem was encountered.The target lesion was located in the left common iliac vein.A 16x90/9fr wallstent uni stent was advanced but the distal end of the stent was rapidly shortened by about 3cm, and another 16x90/9fr wallstent uni stent was needed.During procedure, the vessel changed shape after the stent was placed because the sheath was too hard, and the second stent could not be advanced.The physician gave up connecting the stent for safety reason and removed the stent.No patient complications were reported and the patient was stable.

• Brand Name: WALLSTENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS WI
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10537327
• MDR Text Key: 207041152
• Report Number: 2134265-2020-12748
• Device Sequence Number: 1
• Product Code: MIR
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (y/n): N
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0025028319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 60