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

Model Number 26921

Device Problems Activation, Positioning or Separation Problem (2906); Poor Visibility (4072)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that the device was unable to be seen on imaging.A 6 x 100 x 130 innova self-expanding stent was selected for use in the left ischemic superficial femoral artery.During stent deployment under digital subtraction angiography (dsa), the stent was not imaged clearly, and the marker bands were blurry.Under the image, the stent was not well deployed.After the stent was fully released, the catheter was withdrawn, but it was noted that the stent was not released in the blood vessel but released inside the catheter.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition following the procedure.

Event Description

It was reported that the device was unable to be seen on imaging.A 6 x 100 x 130 innova self-expanding stent was selected for use in the left ischemic superficial femoral artery.During stent deployment under digital subtraction angiography (dsa), the stent was not imaged clearly, and the marker bands were blurry.Under the image, the stent was not well deployed.After the stent was fully released, the catheter was withdrawn, but it was noted that the stent was not released in the blood vessel but released inside the catheter.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition following the procedure.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The stent was damaged and no longer inside the delivery system.The stent was x-rayed, and the stent was visible under fluoroscopy.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16896928
• MDR Text Key: 314891635
• Report Number: 2124215-2023-22649
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0030077380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Sex: Male
• Patient Weight: 65 KG