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

Model Number	26265
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was not fully reconstrained.The stenosed target lesion was located in the non tortuous and non calcified biliary tract.Pre-dilatation was performed and a 8x60x75/ 6f wallstent rp endoprosthesis was advanced for treatment.During the stent implantation process, the stent delivery shaft had been advanced to the end, however, the stent was not deployed although the physician tried to deploy it three times.The stent was not able to be fully reconstrained when removed from the patient's body.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr.: a reduced wallstent device was returned for analysis.A visual and tactile examination identified multiple shaft kinks along the length of the shaft.The device was received with the stent deployed from the delivery system.The deployed stent was not returned for analysis.This concludes the product analysis.
Event or Problem Description
It was reported that the stent was not fully resconstrained.The stenosed target lesion was located in the non tortuous and non calcified biliary tract.Pre-dilatation was performed and a 8x60x75/ 6f wallstent rp endoprosthesis was advanced for treatment.During the stent implantation process, the stent delivery shaft had been advanced to the end, however, the stent was not deployed although the physician tried to deploy it three times.The stent was not able to be fully reconstrained when removed from the patient's body.The procedure was completed with another of same device.There were no patient complications reported and the patient 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14552292
• Report Number: 2134265-2022-05753
• Device Sequence Number: 15147315
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 07/02/2023
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0027601264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 73 KG