MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20212

Device Problem Premature Activation (1484)

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

Event Date 09/13/2022

Event Type  Injury  

Event Description

It was reported that additional intervention was required for a dislodged stent.An express ld balloon expandable stent was selected for use to be implanted in the renal artery.The stent delivery system was advanced to the target location.However, the stent was inadvertently deployed in the incorrect location.A second express ld stent was selected for use.However, this stent moved on the balloon and had to be removed through the sheath.A third express ld stent was selected, and it was successfully implanted next to the first stent.There were no patient complications.

Event Description

It was reported that additional intervention was required for a dislodged stent.An express ld balloon expandable stent was selected for use to be implanted in the renal artery.The stent delivery system was advanced to the target location.However, the stent was inadvertently deployed in the incorrect location.A second express ld stent was selected for use.However, this stent moved on the balloon and had to be removed through the sheath.A third express ld stent was selected, and it was successfully implanted next to the first stent.There were no patient complications.

Manufacturer Narrative

Device eval by mfr: the device was returned, and analysis was completed.A visual examination identified inflation media within the balloon which indicates it had been subjected to positive pressure.The stent had been deployed from the balloon.The stent was deployed inside the patient and was not returned for analysis.No damage or issues were noted with balloon material that could potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination of the device identified no issues with the markerbands or tip that could have contributed to the complaint incident.

• Brand Name: EXPRESS LD VASCULAR
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: 15490785
• MDR Text Key: 300639164
• Report Number: 2124215-2022-37738
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0024936457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention