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

Model Number	26265
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent size incorrect for the lesion occurred.A 8x80x75/ 6f wallstent was advanced to treat the lesion located in the bile duct.However, when the physician released the stent, it was found that the length of the stent was incorrect for the lesion details.The device was removed with a snare and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received fully constrained and the stent in the correct position on the device.The stent was deployed successfully without any resistance or issues experienced.No issues were noted with the stent cups or stent holder.No damage or issues were identified with the deployed stent.The inner and outer diameter of the stent was measured and the length was within specification.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination identified no issues with the tip of the device.No issues were identified during the product analysis.
Event or Problem Description
It was reported that stent size incorrect for the lesion occurred.A 8x80x75/6f wallstent was advanced to treat the lesion located in the bile duct.However, when the physician released the stent, it was found that the length of the stent was incorrect for the lesion details.The device was removed with a snare and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the stent was too long for the lesion details.

• 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: 8544594
• Report Number: 2134265-2019-04244
• Device Sequence Number: 1744108
• Product Code: FGE
• UDI-Device Identifier: 08714729406419
• UDI-Public: 08714729406419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K992510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 05/04/2019
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0020603923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: 59 YR
• Patient Weight: 60