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

Catalog Number	1012580-19
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	03/04/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left main to proximal left anterior descending (lad) coronary arteries.The 4.0x19 mm graftmaster covered stent was implanted in the ostial lad, a 3.5x19 mm graftmaster was implanted in the left main coronary artery and a 2.8x19 mm graftmaster was implanted in the proximal lad.Reportedly, the devices were implanted without issue but the perforation was not sealed.The patient developed multiple episodes of ventricular fibrillation, cardiopulmonary resuscitation (cpr) was performed, and the patient was shocked and medication given.However, the patient reportedly expired due to ventricular fibrillation and uncontrolled perforation.In the physician's opinion, the patients health was declining towards death prior to use of the graftmaster devices and the graftmaster devices did not cause or contribute to the patient death.Although requested, very few details were received, therefore, the relationship, if any, of the graftmaster devices to the reported patient effects are unknown.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.The additional graftmaster devices referenced in b5 are filed under separate medwatch report numbers.
Additional Manufacturer Narrative
The device was not returned for analysis.Lot history record (lhr) and corrective and preventive action (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effects of ventricular fibrillation and death, as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), are known patient effects that may be associated with use of a coronary stent in native coronary arteries.In the physician's opinion, the death was not related to the graftmaster stents, and the patient health was declining (toward death) prior to graftmaster use.Although requested, very few details were received; therefore, the relationship, if any, of the graftmaster devices to the reported patient effects are unknown.A medical review was performed by an abbott vascular clinical specialist.The reviewer concluded that this was a case to treat a perforation in the left main to the proximal left anterior descending (prox.Lad) artery.Due to the information provided, it can be definitively stated that the graftmaster stent was not the cause of death for this patient.However, it may have contributed to the death.It was reported that there was no issue with the deployment of the graftmaster stent; however, it failed to seal the perforation.The physician stated that the graftmaster did not cause or contribute to the patient¿s death and that they were declining prior to the use of the graftmaster stent.The patient experienced multiple episodes of ventricular fibrillation (vf).The patient expired in the cath lab.The cause of death was ventricular fibrillation and uncontrollable perforation.Failure to seal the perforation may be attributed to several factors including, but not limited to, patient anatomical morphology, product size selection, deployment technique (non-central positioning of stent graft over perforation or inadequate overlapping), interference from previously deployed devices, or growth of perforation during deployment.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.In this case, due to the information provided, it can be definitively stated that the graftmaster stent was not the cause of death for this patient.However, it may have contributed to the death.It is possible that the perforation exceeded the length of the stent implanted and the perforation was discovered to be larger than initially anticipated/ visualized angiographically, causing the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak.The relationship, if any, of the graftmaster devices to the reported patient effects are unknown.The investigation determined the reported treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
Na.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left main to proximal left anterior descending (lad) coronary arteries.The 4.0x19 mm graftmaster covered stent was implanted in the ostial lad, a 3.5x19 mm graftmaster was implanted in the left main coronary artery and a 2.8x19 mm graftmaster was implanted in the proximal lad.Reportedly, the devices were implanted without issue but the perforation was not sealed.The patient developed multiple episodes of ventricular fibrillation, cardiopulmonary resuscitation (cpr) was performed, and the patient was shocked and medication given.However, the patient reportedly expired due to ventricular fibrillation and uncontrolled perforation.In the physician's opinion, the patients health was declining towards death prior to use of the graftmaster devices and the graftmaster devices did not cause or contribute to the patient death.Although requested, very few details were received; therefore, the relationship, if any, of the graftmaster devices to the reported patient effects are unknown.Subsequent to the initially filed reports, it was reported that the 4.0x19 mm graftmaster was implanted at 15 atmospheres (atm), the 3.5x19 mm graftmaster was implanted at 20 atm and the 2.8x19 mm graftmaster was implanted at 16 atm.No additional information was provided.

• 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: 19007794
• Report Number: 2024168-2024-03918
• Device Sequence Number: 15795773
• Product Code: MAF
• UDI-Device Identifier: 08717648176357
• UDI-Public: (01)08717648176357(17)241231(10)3012541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 04/29/2024

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: 12/31/2024
• Device Catalogue Number: 1012580-19
• Device Lot Number: 3012541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 04/17/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/12/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X19 MM GRAFTMASTER.; 4.0X19 MM GRAFTMASTER.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 53 KG