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

Catalog Number	1012582-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Hematoma (1884); Swelling/ Edema (4577)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the saphenous vein graft to right coronary artery (svg to rca).After a 5x50mm unspecified stent was implanted a perforation was noted; therefore, a 4.0x16mm graft master stent was implanted in an attempt to seal the perforation; however, the perforation was not sealed.Another non-abbott stent was used to seal the perforation.After the procedure the patient began experiencing superior vena cava (svc) syndrome symptoms as swelling, jugular vein distention (jvd) and chest pain; therefore, it was noted that a hematoma had developed in the mediastinum.The next day a mediastinotomy was performed to aspirate the hematoma.There were no adverse patient sequela and no clinically significant delay.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.
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 (failure to seal); however, the subsequent treatments appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effect of surgical intervention, as listed in the graftmaster rx coronary stent graft system, instructions for use, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Additional information reported that the patient was given iv pain medicine for the chest pain and blood pressure control, and fluids.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: 17878477
• Report Number: 2024168-2023-10904
• Device Sequence Number: 7409200
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/30/2023

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: 1012582-16
• Device Lot Number: 3012541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 104 KG