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

Model Number 26921

Device Problem Premature Activation (1484)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that stent premature deployment occurred.The 80% stenosed, and 13-cm long target lesion was located in the middle part of the iliac artery.After crossing the lesion with a guidewire, balloon pre-dilation was performed.An 8 x 150 x 130 innova stent was selected for use; however, during unpacking, it was found that part of the stent had been deployed outside the protective sheath.The procedure was completed with another of same device.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

The device was returned for evaluation.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed approximately 1cm from the middle sheath.There is a kink to the outer sheath at the nosecone and 3.7cm from the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured location.No other issues were identified during the product analysis.

Event Description

It was reported that stent premature deployment occurred.The 80% stenosed, and 13-cm long target lesion was located in the middle part of the iliac artery.After crossing the lesion with a guidewire, balloon pre-dilation was performed.An 8 x 150 x 130 innova stent was selected for use; however, during unpacking, it was found that part of the stent had been deployed outside the protective sheath.The procedure was completed with another of same device.There were no complications reported and the patient was stable post procedure.

• 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: 19028765
• MDR Text Key: 339221758
• Report Number: 2124215-2024-16192
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/25/2024

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: 0031376474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 70 KG