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

Model Number 26280

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A 14x90/9fr uni plus 75cm wallstent uni was selected for treatment in the iliac artery.When a second release of stent was done, it was noted that this device was deformed on the tip.The device was removed and replaced with another of the same product to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.The wallstent device was received by the manufacturer: a visual examination found the stent to be partially deployed on the delivery system.The distal stent wires were noted to be damaged.No issues were noted with the delivery system during analysis.The product record review confirmed that this is not a new failure type, and the risk is anticipated.

Event Description

It was reported that stent damage occurred.A 14x90/9fr uni plus 75cm wallstent uni was selected for treatment in the iliac artery.When a second release of stent was done, it was noted that this device was deformed on the tip.The device was removed and replaced with another of the same product to complete the procedure.There were no patient complications reported.It was further reported that the target lesion was of 60% stenosis and was moderately tortuous and severely calcified.The wallstent device was received by the manufacturer: a visual examination found the stent to be partially deployed on the delivery system.The distal stent wires were noted to be damaged.No issues were noted with the delivery system during analysis.The product record review confirmed that this is not a new failure type, and the risk is anticipated.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18426869
• MDR Text Key: 331912228
• Report Number: 2124215-2023-74518
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0031357052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG