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

Model Number	1012581-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the mid left anterior descending (lad) coronary artery.The 3.5x16 mm graftmaster covered stent was implanted but there was still extravasation of contrast proximal to the stent edge due to the perforation being larger than anticipated and the position of the stent.Therefore, the 4.0x16 mm graftmaster covered stent was implanted and sealed the perforation.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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.A conclusive cause for the reported patient-device incompatibility (failure to seal) could not be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.Patient-device incompatibility (failure to seal the perforation) may be attributed to several factors including, but not limited to, patient anatomical morphology, product size selection, deployment technique, interference from previously deployed devices, or growth of perforation during deployment.In this case, it is possible that the perforation was larger than anticipated, causing the reported patient-device incompatibility (failure to seal).Another graftmaster stent was implanted which sealed the perforation; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 22118298
• Report Number: 2024168-2025-05538
• Device Sequence Number: 20598813
• Product Code: NIV
• UDI-Device Identifier: 08717648176395
• UDI-Public: (01)08717648176395(17)260131(10)4021341
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/20/2025

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?: 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White