MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26920

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/22/2024

Event Type  Injury  

Event Description

It was reported that stent damage occurred, and additional intervention done to remove the stent and open the vessel.The patient was being treated for peripheral arterial disease in the moderately tortuous superficial femoral artery.The lesion was predilated at 4 atmospheres and post dilated at 5 atmospheres using a mustang balloon catheter.A 5x200x130 innova was selected for treatment.However, during deployment, the stent was not able to open up and there was foreshortening in the stent length from 200mm to 140mm.It was also noted that the stent was crumpled at the distal end, and there was no flow in the artery.The patient was referred for surgery to open the vessel.

Event Description

It was reported that stent damage occurred, and additional intervention done to remove the stent and open the vessel.The patient was being treated for peripheral arterial disease in the moderately tortuous superficial femoral artery.The lesion was predilated at 4 atmospheres and post dilated at 5 atmospheres using a mustang balloon catheter.A 5x200x130 innova was selected for treatment.However, during deployment, the stent was not able to open up and there was foreshortening in the stent length from 200mm to 140mm.It was also noted that the stent was crumpled at the distal end, and there was no flow in the artery.The patient was referred for surgery to open the vessel.It was further reported that the physician used surgical approach for the treatment and did femoropopliteal bypass graft placement.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18952011
• MDR Text Key: 338265883
• Report Number: 2124215-2024-12685
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0031291272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: Asian