MAUDE Adverse Event Report: ABBOTT VASCULAR INC. GRAFTMASTER; CORONARY COVERED STENT

Model Number	1012581-16
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - above rated burst pressure.
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation.The 3.5x16mm graftmaster covered stent was deployed at 18 atmospheres and noted to seal the perforation.However, post procedure it was noted the covered stent "abrupt closure" [occluded]; however, it is unknown if treatment was provided.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.It was reported that the 3.5x16mm graftmaster covered stent was deployed at 18 atmospheres and noted to seal the perforation.It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use (ifu) specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.In this case, it is unknown if the ifu deviation contributed to the reported event.The reported patient effect of occlusion is listed in the graftmaster rx coronary stent graft systems ifu as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation.The 3.5x16mm graftmaster covered stent was deployed at 18 atmospheres and noted to seal the perforation.However, post procedure it was noted the covered stent "abrupt closure" [occluded]; however, it is unknown if treatment was provided.There was no clinically significant delay reported.No additional information was provided.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY COVERED STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23557804
• Report Number: 2024168-2025-11530
• Device Sequence Number: 15909999
• Product Code: NIV
• UDI-Device Identifier: 08717648176395
• UDI-Public: (01)08717648176395(17)260131(10)4021341
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/12/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 1012581-16
• Device Catalogue Number: 1012581-16
• Device Lot Number: 4021341
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male