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

Model Number 26921

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that stent partial deployment occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderate to severely calcified lower extremity iliac artery in a contralateral approach.Pre-dilatation was performed prior to deployment and elevated force was used to turn the thumbwheel.An 8 x 100 x 130 innova stent was advanced for treatment but it got stuck while being deployed and was unable to fully expand.The device was removed and replaced with another of the same model.No complications were reported and the patient's status was stable.

Manufacturer Narrative

The complaint device was not received at the complaint investigation site (cis) for analysis.

Manufacturer Narrative

Device was returned to the manufacturer: the outer sheath, tip, inner sheath and the remainder of the innova stent system were checked.No damages noted visually and microscopically.The thumbwheel lock and pull rack are still in the manufactured position.There are no blood or fluid inside the sheath to suggest it may have been used in a procedure.There were no irregularities nor other damages revealed.

Event Description

It was reported that stent partial deployment occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderate to severely calcified lower extremity iliac artery in a contralateral approach.Pre-dilatation was performed prior to deployment and elevated force was used to turn the thumbwheel.An 8 x 100 x 130 innova stent was advanced for treatment but it got stuck while being deployed and was unable to fully expand.The device was removed and replaced with another of the same model.No complications were reported and the patient's status was stable.

• 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: 18511199
• MDR Text Key: 333201360
• Report Number: 2124215-2023-76000
• 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: 03/11/2024

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: 0029185756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 74 KG