MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Graftmaster; Coronary Covered Stent

Model Number	1012581-19
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction

• Brand Name: Graftmaster
• Common Device Name: Coronary Covered Stent
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50193057
• Report Number: 2024168-2026-03124
• Device Sequence Number: 9887141
• Product Code: NIV
• UDI-Device Identifier: 08717648176401
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 1012581-19
• Device Catalogue Number: 1012581-19
• Device Lot Number: 4052041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male