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

Model Number	26280
Medical Device Problem Codes	Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent dislodged.The 90% stenosed target lesion was located in the precaval.A 75cm wallstent endoprosthesis stent was inserted.The stent was slowly released at the lesion site, however, the position was not ideal.The physician withdrew the device, and afterwards the stent dislodged.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that the stent dislodged.The 90% stenosed target lesion was located in the precaval.A 75cm wallstent endoprosthesis stent was inserted.The stent was slowly released at the lesion site, however, the position was not ideal.The physician withdrew the device, and afterwards the stent dislodged.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the stent deployed when the physician tried to re-constrain it.The stent deployed in an un-ideal position and re-constrainment of the device failed.The device had to be removed by a snare.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination identified no issues with the delivery system that could potentially have contributed to the complaint incident.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.The device was received with the stent fully deployed.The deployed stent was returned for analysis.No damage or issues were noted with the returned stent that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent dislodged.The 90% stenosed target lesion was located in the precaval.A 75cm wallstent endoprosthesis stent was inserted.The stent was slowly released at the lesion site, however, the position was not ideal.The physician withdrew the device, and afterwards the stent dislodged.The procedure was completed with a different device.There were no patient complications reported.It was furter reported that the stent deployed when the physician tried to reconstrain it.The stent deployed in an unideal position and reconstrainment of the device failed.The device had to be removed by a snare.

• 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: 8465449
• Report Number: 2134265-2019-03228
• Device Sequence Number: 16203237
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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 Expiration Date: 06/25/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022301762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/31/2019; 04/15/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/05/2019; 05/02/2019
• 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
• Patient Age: 75 YR