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

Model Number 26921

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It was reported that the innova stent was partially deployed.An innova-china 5 x 150 x 130 was selected for use in the femoral artery to treat lower limb stenosis.When the physician attempted to deploy the stent, there was high force required to turn the thumbwheel.When approximately one quarter of the stent was deployed, the thumbwheel jammed.The pull grip was unable to be pulled to fully deploy the stent.The partially deployed stent was removed without issue and the device was replaced with another innova to complete the procedure.There were no reported patient complications.

Manufacturer Narrative

Device analysis: 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 that the handle was open.There were tool marks on the handle and pull rack.The stent was partially deployed 7.3cm from the distal end of the middle sheath.Microscopic and visual examination of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed that the stent was partially deployed.

Event Description

It was reported that the innova stent was partially deployed.An innova-china 5 x 150 x 130 was selected for use in the femoral artery to treat lower limb stenosis.When the physician attempted to deploy the stent, there was high force required to turn the thumbwheel.When approximately one quarter of the stent was deployed, the thumbwheel jammed.The pull grip was unable to be pulled to fully deploy the stent.The partially deployed stent was removed without issue and the device was replaced with another innova to complete the procedure.There were no reported patient complications.

• 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: 17785300
• MDR Text Key: 323876686
• Report Number: 2124215-2023-50931
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• 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: 0031390100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG