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

Model Number	26280
Medical Device Problem Codes	Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Codes	Pain (1994); Complaint, Ill-Defined (2331)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the stent failed to fully open and the patient experienced pain.The 14mm diameter target lesion was located in the renal vein.After the 260cm amplatz was passed through, a 14x40/9fr uni plus 75cm wallstent endoprosthesis was used for treatment.However, the stent failed to fully expand and then became too long to touch the inferior vena cava (ivc).The patient began to feel pain.When the physician looked at the image, he found out that the aorta and the superior mesenteric artery were oppressed and thought it might have caused the wallstent to not to fully expand.The physician worried about ivc rupture.The patient was arranged for prolonged hospitalization and observation.

• 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: 8153284
• Report Number: 2134265-2018-63849
• Device Sequence Number: 2189955
• Product Code: MAF
• UDI-Device Identifier: 08714729203995
• UDI-Public: 08714729203995
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 08/23/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021045848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: Hospitalization