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

Catalog Number	1012581-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left anterior descending (lad) coronary artery.The 3.5x16 mm graftmaster covered stent was implanted; however, the perforation was not sealed.While the graftmaster covered stent reportedly did not cause or contribute to complications or adverse events, the patient ultimately expired.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.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left anterior descending (lad) coronary artery.The 3.5x16 mm graftmaster covered stent was implanted; however, the perforation was not sealed.While the graftmaster covered stent reportedly did not cause or contribute to complications or adverse events, the patient ultimately expired.Subsequent to the initially filed report, it was reported that the patient presented with st elevated myocardial infarction.There was no issue with the graftmaster, it just did not seal the perforation.Balloon dilatations were performed on the graftmaster stent but aborted as the patient required cardiopulmonary resuscitation (cpr) due to ventricular fibrillation.There were no adverse effects due to the graftmaster and the physician stated that the device did not cause or contribute to the patient death as the patient was declining toward death prior to use of the graftmaster.The cause of death was ventricular fibrillation which the patient never recovered from.No additional information was provided.
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 investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak; however, the reported patient effect of unrelated death was due to ventricular fibrillation which the patient never recovered from and not related to the device or procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B2 - outcomes attributed to ae: "death" was removed and replaced with "na".H1 - type of reportable event updated from "death" to "serious injury." h6 - health effect - impact code 1802 was removed and code 4641 was added; health.Effect - clinical code 4454 was removed and code 4582 was added.

• 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: 18337764
• Report Number: 2024168-2023-14089
• Device Sequence Number: 6937771
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: 08717648176395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/12/2024

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: 02/29/2024
• Device Catalogue Number: 1012581-16
• Device Lot Number: 2033141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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; Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG