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

Model Number 26920

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the stent was difficult to deploy and was malpositioned.This 6x200x130 innova stent system was selected for use in a stenting procedure.The 70% stenosed, moderately calcified, moderately tortuous lesion was located in the superficial femoral artery.The lesion was pre-dilated with a 4x150 mustang balloon.During deployment of this stent via a contralateral approach, the delivery system malfunctioned, and the stent was malpositioned.It was noted that the stent deployed smoothly up to approximately 120mm.Then the pull grip was used to release the full stent; however, after 120mm resistance was felt on the pull grip.The stent was able to be deployed and fully covered the lesion and there were no 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: 18016531
• MDR Text Key: 327712009
• Report Number: 2124215-2023-59047
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0031291273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4X150 MUSTANG BALLOON
• Patient Age: 62 YR
• Patient Sex: Female