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

Model Number 26926

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

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

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was noted that stent partial deployment and stent fracture occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified left distal superficial femoral artery and external iliac artery.Physician had crossed an old occluded in-stent stenosis.A laser atherectomy was then performed to prepare the vessel prior to deployment of the stent.Afterwards, a 5 x 150 x 130 innova stent was sent to realign the fractured old stent segment.However, physician struggled to track stent over a.014 pt choice wire, but eventually aligned stent where it was wanted.During the deployment, it was noted that the thumb wheel was not deploying the stent and when it was retracted, the stent was partially deployed about 10mm.Part of the stent was still in the body as the remaining stent was now located in the sheath, so the sheath and stent was removed together.The physician decided to send a sterling balloon catheter to deploy the remaining stent portion and the procedure was completed with a 6x60 innova.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open.The middle sheath is separated 16cm from the distal end.There are multiple areas of buckling to the outer and middle sheath.The pull rack is separated.The separated distal section is stuck inside the nosecone while the separated proximal section is missing.The stent is no longer inside the middle sheath.Inspection of the remainder of the device, revealed no other damage or irregularities.The information provided suggested the customer used an undersized guidewire during deployment which likely led to insufficient support contributing damage found during analysis and the report from the field.

Event Description

It was noted that stent partial deployment and stent fracture occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified left distal superficial femoral artery and external iliac artery.Physician had crossed an old occluded in-stent stenosis.A laser atherectomy was then performed to prepare the vessel prior to deployment of the stent.Afterwards, a 5 x 150 x 130 innova stent was sent to realign the fractured old stent segment.However, physician struggled to track stent over a.014 pt choice wire, but eventually aligned stent where it was wanted.During the deployment, it was noted that the thumb wheel was not deploying the stent and when it was retracted, the stent was partially deployed about 10mm.Part of the stent was still in the body as the remaining stent was now located in the sheath, so the sheath and stent was removed together.The physician decided to send a sterling balloon catheter to deploy the remaining stent portion and the procedure was completed with a 6x60 innova.No patient complications were reported.

• Brand Name: INNOVA VASCULAR
• 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: 18912302
• MDR Text Key: 337756962
• Report Number: 2124215-2024-12688
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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 Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0032186978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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