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

Model Number	1012584-16
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiogenic Shock (2262); Respiratory Failure (2484); Foreign Body In Patient (2687); Pericardial Effusion (3271)
Date of Event	02/10/2026
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.
Event or Problem Description
It was reported that procedure was to treat a perforation in the ostial proximal left anterior descending (lad) and distal left main trunk (lmt) arteries.The 4.8x16m graftmaster covered stent was advanced to the target lesion and the stent was implanted; however, post deployment the shaft separated during removal in the aorta.The separated balloon was snared from the patient, which caused a clinically significant delay in treating a noted residual leak where the stent was implanted.The patient went into shock, respiratory failure and pericardial effusion was noted which required pericardiocentesis and an impella device.Another graftmaster stent was used to continue the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the graftmaster device was difficult to position and stent appeared to be coming off the delivery system balloon.Therefore, the graftmaster stent was implanted in healthy tissue.Post deployment the shaft became separated and had to be snared.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported shaft separation was confirmed.The reported stent dislodgement could not be confirmed because the stent was not returned and the balloon was returned inflated.The reported difficult/delayed positioning could not be replicated, as it was related to the procedural context.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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.Factors that may contribute to difficult or delayed positioning include patient anatomy, disease state, pre-dilatation strategy, device placement technique, material properties, incorrect contrast mix, and device preparation.Based on the information provided, the cause of the reported difficult or delayed positioning could not be determined.The reported stent dislodgement and shaft separation appear related to the difficult/delayed positioning, as the device was reportedly moved back and forth through the vessel.This movement, combined with interaction with patient anatomy and/or procedural accessories, likely contributed to the stent dislodgement and shaft separation.The dislodged stent was deployed in healthy tissue, and the separated shaft portion was successfully snared.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears related to the operational context of the procedure.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 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--462 ; 9519143996
• MDR Report Key: 24524525
• Report Number: 2024168-2026-00928
• Device Sequence Number: 9746573
• Product Code: NIV
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 1012584-16
• Device Catalogue Number: 1012584-16
• Device Lot Number: 4112941
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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: 63 YR
• Patient Sex: Female