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

Model Number	1012583-26
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	10/10/2025
Type of Reportable Event	Malfunction
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 rx graftmaster was used past the expiration date.A review of the rx graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of 24-october-2023 with an expiration date (use by date) of 30-september-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 instructions for use (ifu) states: note the product ¿use by¿ (expiration) date specified on the package.In addition, it was reported that the procedure was to treat a pseudoaneurysm in the right coronary artery.It should be noted that the graftmaster ifu states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts = 2.75 mm in diameter.The effectiveness of this device for this use has not been demonstrated.Long-term outcome for this permanent implant is unknown at present.The investigation determined the reported device expiration issue appears to be related to the use error.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 medical device problem code: 1494 - indication for use, 2017 - use after expiration.
Event or Problem Description
It was reported that the procedure was to treat a pseudoaneurysm in the right coronary artery.A 4.5x26mm graftmaster covered stent was deployed and post dilation was performed with a 4.5x12mm non-abbott balloon.It was noted that the stent was expired.A 4.0x16mm graftmaster covered stent was deployed successfully and post dilatation was performed with a 4x8mm non-abbott balloon.There was no adverse patient sequela and no clinically significant delay in the procedure.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: 23487654
• Report Number: 2024168-2025-11396
• Device Sequence Number: 10488449
• Product Code: NIV
• UDI-Device Identifier: 08717648176494
• UDI-Public: (01)08717648176494(17)250930(10)3102441
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/06/2025

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: 09/30/2025
• Device Model Number: 1012583-26
• Device Catalogue Number: 1012583-26
• Device Lot Number: 3102441
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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: 68 YR
• Patient Sex: Male