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

Model Number	1012583-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	06/15/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Estimated date.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient presented with a right coronary artery (rca) perforation/artery rupture with hemopericardium with cardiac tamponade.The patient had become hemodynamically unstable and balloon angioplasty was performed, however, the bleeding continued.A 4.50x19mm (1012583-19, 8120441) a graftmaster stent was implanted without a device issue reported, sealing the perforation.On an unspecified date, a possible subacute stent thrombosis occurred and the patient had expired.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
B2, b3: estimated.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effects of thrombosis and death are listed in the graftmaster rx coronary stent graft system, instructions for use as known patient effects that may be associated with use of a coronary stent in native coronary arteries.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 of the device.

• 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
• MDR Report Key: 10248729
• Report Number: 2024168-2020-05583
• Device Sequence Number: 515354
• Product Code: MAF
• UDI-Device Identifier: 08717648176487
• UDI-Public: 08717648176487
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 11/30/2020
• Device Model Number: 1012583-19
• Device Catalogue Number: 1012583-19
• Device Lot Number: 8120441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR