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

Model Number 26920

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.During the procedure to deploy this 6x150x75 innova stent, it did not release completely, and the knob was blocked.The surgeon finished releasing the stent in a fixed-point withdrawal position.There were no patient clinical consequences.

Event Description

It was reported that the stent partially deployed.During the procedure to deploy this 6x150x75 innova stent, it did not release completely, and the knob was blocked.The surgeon finished releasing the stent in a fixed-point withdrawal position.There were no patient clinical consequences.It was further reported that the lesion was at stage four of the right lower limb.The femoral artery had multistage stenosis up to the hunters canal, with thrombosis with recovery above the joint and downstream.The anterior tibial artery had further thrombosis and there was long stenosis of the posterior tibial.Additionally, the non-boston scientific guidewires reportedly failed; therefore, the decision was made to use a retrograde approach via popliteal puncture with ultrasound imaging.Once a 5fr introducer was advanced and recanalization was performed, exchange of the through and through guidewire for a 0.018 guidewire was then completed.It was further noted that the stent did not deploy despite a high intensity to turn the thumb wheel.

• 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: 17329585
• MDR Text Key: 319511491
• Report Number: 2124215-2023-36769
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0028125724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASTATO; GLADIUS; SILVERWAY GUIDE; TERUMO STIFF