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

Model Number	26280
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age of time of event: 18yrs or older.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the renal vein.After crossing a guide wire into the renal vein down to the ovarian vein, a 16x40/9fr wallstent endoprosthesis stent was advanced to treat the lesion.The stent was 4cm long and the distance between the ovarian vein (ov) and the inferior vena cava (ivc) was approximately 4cm.The stent was successfully deployed with one end near the ostium of the ov and the other end just inside the ivc.However, upon removing the delivery system, the stent migrated back into the ivc.It was unclear if the stent caught up with the delivery system during removal resulting in migration or if the stent jumped back during deployment since the stenosis appeared to be right up against the ov which was at the distal part of the stent.The stent was then partially snared and was pulled back into the femoral vein.A small cutdown was performed to remove the stent from the patient's femoral vein.No further patient complications were reported and the patient was stable.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9418290
• Report Number: 2134265-2019-15095
• Device Sequence Number: 1671329
• Product Code: MAF
• UDI-Device Identifier: 08714729204039
• UDI-Public: 08714729204039
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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
• Operator of Device: Health Professional
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021703513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/05/2019
• 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: Required Intervention