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

Model Number	1012580-16
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	03/04/2025
Type of Reportable Event	Malfunction
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: use after expiration and above rbp.H6 medical device problem code: 1494: indication for use.
Event or Problem Description
It was reported that the procedure was to treat an aneurysm the mid left anterior descending (lad) artery.The graftmaster stent was advanced to the aneurysm and was implanted at 20 atmospheres (atm); however, post stent implantation the graftmaster stent was noted to be expired.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.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 specific issue.It was reported that the graftmaster was implanted at 20 atmospheres (atm) however, post stent implantation the device was noted to be expired.A review of the graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of 21-march-2023 with an expiration date (use by date) of 28-february-2025.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2025.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, (ifu, states: note the product use by date specified on the package.Additionally, 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.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, instructions for use, (ifu, states: the graftmaster rx is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of acute coronary artery perforations and acute coronary artery ruptures.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event.Based on the information received, the investigation determined that the reported device expiration issue and inflation above instructions for use rated burst pressure appears to be related to user error.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• 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: 21713330
• Report Number: 2024168-2025-03176
• Device Sequence Number: 15955138
• Product Code: MAF
• UDI-Device Identifier: 08717648176340
• UDI-Public: (01)08717648176340(17)250228(10)3032141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 02/28/2025
• Device Model Number: 1012580-16
• Device Catalogue Number: 1012580-16
• Device Lot Number: 3032141
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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: 84 YR
• Patient Sex: Female