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

Model Number H74939293051530

Device Problems Entrapment of Device (1212); Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

Physician attempted to deploy a 5 mm by 150 mm stent into the superior femoral artery (sfa), while deploying the stent, physician was unable to fully deploy the stent due to trapping of the stent within the sub-intimal plane.Physician subsequently had to remove the entire delivery sheath and delivery catheter for the stent from the right groin.Manual pressure was then held in the groin for hemostasis.Next, retrograde injections were performed through the pedal access sheath which showed patent popliteal artery, tibioperoneal (tp) trunk and posterior tibial artery.Next, the arterial sheath was removed from the pedal access site and manual pressure held here for hemostasis.Overall, the patient tolerated the procedure well and was transferred to the post-anesthesia care unit (pacu) in a stable condition.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlbourough MA 01752 1234
• MDR Report Key: 8415861
• MDR Text Key: 138689986
• Report Number: 8415861
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2019

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: H74939293051530
• Device Catalogue Number: H74939293051530
• Device Lot Number: 21955574
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 57