MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT BARE METAL MINI VISION RX STENT; STENT, CORONARY

Model Number 1007823-23

Device Problems Migration or Expulsion of Device (1395); Failure to Deliver (2338)

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

Event Date 10/31/2022

Event Type  Injury  

Event Description

Unable to deliver the stent to the lesion.Stent embolized to the rt.Femoral artery during removal of the stent.Radiologist into review the cine images surgeon into consult for stent removal from femoral artery site.Pt.Transferred to operating room for removal of the stent , stable, wife and son informed of the situation by physician.Abbot bare metal mini vision rx; 535 gtin: (b)(4).Fda safety report id# (b)(4).

• Brand Name: ABBOTT BARE METAL MINI VISION RX STENT
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 15760433
• MDR Text Key: 303428606
• Report Number: MW5113174
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648049538
• UDI-Public: 08717648049538
• 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: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1007823-23
• Device Catalogue Number: 1007823-23
• Device Lot Number: 1010641913260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 25 KG
• Patient Ethnicity: Hispanic