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

Model Number	1012580-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation (2001); Cardiac Tamponade (2226)
Date of Event	10/28/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of death, as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu) is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.Additionally a medical review was performed by an abbott vascular medical reviewer who concluded that the cause of death was not reported, but was most likely from cardiac tamponade and hemorrhagic shock due to the unsealed perforation.The failures of the graftmaster stents to cross due to the calcified anatomy, were an indirect cause of this patient¿s death.The investigation determined the reported failure to advance appears to be related to the operational context of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent (delay in treatment) 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.The 3.5 x 19 mm graftmaster stent delivery system referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the calcified left anterior descending (lad) artery.A perforation occurred during use of an unspecified device.The patient experienced cardiac tamponade and cardiopulmonary resuscitation (cpr) was performed.The 3.5 x 19 mm graftmaster stent delivery system was advanced into the patient anatomy; however, due to the patient anatomy and cpr, the device was unable to cross and was removed.The 2.8 x 26 mm graftmaster stent delivery system was then advanced into the patient anatomy; however, this device was also unable to cross.The patient condition continued to decline and a clinically significant delay was reported related to the failure to cross of both devices.A dilatation catheter was advanced to the target site and inflated, sealing the perforation; however, the patient died on (b)(6) 2021.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: 12855810
• Report Number: 2024168-2021-10687
• Device Sequence Number: 4828972
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: 08717648176364
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 12/31/2022
• Device Model Number: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 1012541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 78 KG