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

Model Number 26920

Device Problems Defective Device (2588); Poor Visibility (4072)

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

Event Date 01/09/2023

Event Type  Injury  

Event Description

It was reported that the stent foreshortened and was difficult to see under fluoroscopy.A 5x40x130 innova self-expanding stent was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery.A contralateral approach was used to access the vessel with a 7mm diameter.The lesion was pre and post dilated; however, the stent did not deploy well because the stent strut was difficult to see under fluoroscopy.The stent fully expanded, but it was a little short.Therefore, another innova stent was implanted to treat the lesion.No patient complications were reported.

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 still inside the sheath and did not appear to have been attempted to be deployed.The thumbwheel lock was still in the manufactured position.The stent was measured to be approximately 4cm.The device was x-rayed, and the stent was visible.

Event Description

It was reported that the stent foreshortened and was difficult to see under fluoroscopy.A 5x40x130 innova self-expanding stent was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery.A contralateral approach was used to access the vessel with a 7mm diameter.The lesion was pre and post dilated; however, the stent did not deploy well because the stent strut was difficult to see under fluoroscopy.The stent fully expanded, but it was a little short.Therefore, another innova stent was implanted to treat the lesion.No patient complications were reported.

• 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: 16305572
• MDR Text Key: 308869485
• Report Number: 2124215-2023-04127
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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: 10/23/2023
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0026237158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male