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

Model Number	26280
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that positioning difficulties were encountered.The target lesion was located in a vein.Following thrombectomy with an angiojet and pre-dilatation with a charger balloon catheter, a 12x60/8fr 75cm wallstent endoprosthesis stent was advanced but could not be deployed.The physician tried several times, but the stent could not be positioned accurately.Instead, the physician deployed the stent in situ.The stent was not able to cover the lesion.The procedure was completed with another 12x60 wallstent.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that positioning difficulties were encountered.The target lesion was located in a vein.Following thrombectomy with an angiojet and pre-dilatation with a charger balloon catheter, a 12x60/8fr 75cm wallstent endoprosthesis stent was advanced but could not be deployed.The physician tried several times, but the stent could not be positioned accurately.Instead, the physician deployed the stent in situ.The stent was not able to cover the lesion.The procedure was completed with another 12x60 wallstent.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received with the stent fully deployed from the device as it was implanted in the patient.A visual and microscopic examination identified no damage or issues with the delivery system or shaft or tip of the device that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.

• 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: 10069621
• Report Number: 2134265-2020-06425
• Device Sequence Number: 11732773
• Product Code: MAF
• UDI-Device Identifier: 08714729203964
• UDI-Public: 08714729203964
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 08/06/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022476603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOJET CATHETER; ANGIOJET CATHETER; CHARGER BALLOON CATHETER; CHARGER BALLOON CATHETER; ANGIOJET CATHETER; CHARGER BALLOON CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR