MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Codes	Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received with the stent fully deployed.The device was received with the stent fully deployed from the device the device.It is not known when deployment occurred.The deployed stent was not returned for analysis.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.A visual and tactile examination found no damage or issues to the delivery system that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent partial deployment occurred and the device was removed without reconstraining.The 50-60% stenosed target lesion was located in the mildly tortuous and non-calcified transhepatic biliary.A 8x60x75//6f wallstent rp endoprosthesis was advanced for treatment.However, after the stent sheath reached the target position, the stent could not fully deploy.The stent was not fully reconstrained back into the catheter.The device was simply pulled back and removed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8971200
• Report Number: 2134265-2019-10796
• Device Sequence Number: 19463198
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• 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
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0023239334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 50