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

Model Number 26280

Device Problem Premature Activation (1484)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address 1: (b)(6) hospital.

Event Description

It was reported that inadvertent deployment occurred.The procedure was performed via selective venography.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified venous thrombosis of lower extremity.A 12x90/8fr uni plus halo 75cm wallstent uni was selected for use.It was during procedure that it was found that the stent was unintentionally deployed outside the patient's body.The procedure was completed with a different device and no patient complications were reported.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.It was returned with the stent fully deployed from the delivery system.The deployed stent was not returned for analysis.A visual examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip and sheath of the device.

Event Description

It was reported that inadvertent deployment occurred.The procedure was performed via selective venography.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified venous thrombosis of lower extremity.A 12x90/8fr uni plus halo 75cm wallstent uni was selected for use.It was during procedure that it was found that the stent was unintentionally deployed outside the patient's body.The procedure was completed with a different device and no patient complications were reported.

• 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: 18367467
• MDR Text Key: 331060410
• Report Number: 2124215-2023-71979
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 0030943712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 65 KG