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

Model Number	26927
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent fractured.This 6 x 200 x 130 innova vascular stent was selected for use in a superficial femoral artery intervention procedure.The 85% stenosed, mildly tortuous, moderately calcified lesion was first treated with jetstream atherectomy.This innova stent was subsequently deployed, and then a second innova stent was deployed.Both stents were post dilated with a 5x200 sterling balloon.When dilating the first stent at approximately 8 atmospheres it fractured in the middle.The stent remained patent, and the physician continued post dilating the rest of the stented area without any issues.The stent fracture was visible via x-ray images and was not flow limiting.The procedure was completed and there were no patient complications.
Additional Manufacturer Narrative
The complaint device was not received at the complaint investigation site (cis) for analysis.Media was provided in the form of a photo.The photo showed the stent inside the patient and in the middle of the photo the stent was visibly protruding outwards.
Event or Problem Description
It was reported that the stent fractured.This 6 x 200 x 130 innova vascular stent was selected for use in a superficial femoral artery intervention procedure.The 85% stenosed, mildly tortuous, moderately calcified lesion was first treated with jetstream atherectomy.This innova stent was subsequently deployed, and then a second innova stent was deployed.Both stents were post dilated with a 5x200 sterling balloon.When dilating the first stent at approximately 8 atmospheres it fractured in the middle.The stent remained patent, and the physician continued post dilating the rest of the stented area without any issues.The stent fracture was visible via x-ray images and was not flow limiting.The procedure was completed and there were no patient complications.

• Brand Name: INNOVA VASCULAR
• Common Device Name: 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: 17871341
• Report Number: 2124215-2023-54895
• Device Sequence Number: 7601369
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: 08714729874065
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2025
• Device Model Number: 26927
• Device Catalogue Number: 26927
• Device Lot Number: 0030163412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown