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

Model Number	1007823-23
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 15760433
• Report Number: MW5113174
• Device Sequence Number: 6238647
• Product Code: MAF
• UDI-Device Identifier: 08717648049538
• UDI-Public: 08717648049538
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 25 KG
• Patient Ethnicity: Hispanic