MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Model Number	1012581-26
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	03/15/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the procedure was to treat a perforation in the right coronary artery (rca) with heavy calcification.The 3.5x26mm graftmaster covered stent was deployed but due to improper technique the stent was not implanted and was lost in the aorta.The perforation was not sealed.The use of the graftmaster did not cause or contribute to complications or adverse events.The patient was transferred to another facility and died after other life saving attempts.No additional information was provided.
Additional Manufacturer Narrative
Date of death: estimated.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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of embolism and death, as listed in the graftmaster rx coronary stent graft system, instructions for use are known patient effects that may be associated with use of a coronary stent in native coronary arteries.This event was reviewed by medical affairs who concluded the following: this was a case to treat a 64-year-old male patient whose medical history was not reported.During the interventional procedure of the right coronary artery (rca) the artery was perforated.A graftmaster stent deployment was attempted but failed due to the use of an unreported improper technique.This improper technique led to the graftmaster stent becoming lost within the patient¿s arterial system.This left the perforation unsealed, and the graftmaster became a foreign body that was reportedly not retrieved.The patient was transferred to another hospital, where they expired later that same day.Due to the information provided, it cannot be definitively stated if the graftmaster contributed to this patient's death.The reported but unexplained improper technique led to the failure of the graftmaster stent to seal the perforation and instead become a foreign body and embolize within the patient¿s vasculature, most likely leading to the patient's death.The investigation was unable to determine a conclusive cause for the reported stent migration.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent foreign body in patient appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16701309
• Report Number: 2024168-2023-03582
• Device Sequence Number: 11679197
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 1042941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: Death
• Patient Age: 64 YR
• Patient Sex: Male