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

Model Number	1012582-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2022
Type of Reportable Event	Death
Event or Problem Description
It report that the procedure was to treat an occluded mid right coronary artery (mrca).The patient presented with a cardiac arrest at home and provide with cardiopulmonary resuscitation (cpr).In the er the patient arrested again and was noted to be in ventricular fibrillation, multiple defibrillations and intubated.Medication was also provided; however, arrival to the cath lab patient arrested again requiring several defibrillations.It was noted that the occluded artery had large thrombus burden requiring multiple runs of aspiration thrombectomy and implantation of two unspecified drug-eluting stents.A perforation was noted in the mrca and two (3.5x16mm and 2.8x16mm) graftmasters; however, both failed to seal.A third 4.0x16mm graftmaster was deployed and seal the perforation.However, it was noted patient expired after the procedure.No additional information was provided.
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Estimated date of death- (b)(6) 2022.The additional graftmaster devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
Subsequently, after the initial was filed the account confirm, that the two (3.5x16mm and 2.8x16mm) graftmasters failed to seal due to the perforation being larger than initially anticipated.The patient was noted to be declining in health prior to use of the graftmasters.The patient died of progressive cardiogenic shock and in the physician's opinion, none of the graftmasters caused or contributed to patient's death.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.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 health effect - impact code code 1802 was removed; code 4641 was removed and code 2199 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: 15874688
• Report Number: 2024168-2022-11963
• Device Sequence Number: 14824455
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1012582-16
• Device Catalogue Number: 1012582-16
• Device Lot Number: 2011841
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.8X16MM GRAFTMASTER; 3.5X16MM GRAFTMASTER RX
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 122 KG