MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA STENT; STENTS, SUPERFICIAL FEMORAL ARTERY

Catalog Number S-65-120-120-P6

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 09/13/2019

Event Type  Injury  

Event Description

Procedure: left lower extremity angiogram, recanalization of chronically occluded left superficial femoral artery, and stent placement.During this deployment of the stent, the nose cone of the deployment apparatus became wedged in the tip of the 6 french sheath and detached from the remainder of the deployment apparatus.It was quickly realized that some of the stent remained un-deployed within the 6 french right groin sheath.Fda safety report id# (b)(4).

• Brand Name: SUPERA STENT
• Type of Device: STENTS, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 9166526
• MDR Text Key: 161690054
• Report Number: MW5090254
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2019

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 Catalogue Number: S-65-120-120-P6
• Device Lot Number: 9061761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 77