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

Model Number	26280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
(d4) model number, lot number, catalog number, expiration date, and unique identifier (udi) # updated to unknown.(h4) device manufacture date - unknown.
Event or Problem 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
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10537327
• Report Number: 2134265-2020-12748
• Device Sequence Number: 17115047
• Product Code: MIR
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 10/14/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/02/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 60