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

Catalog Number	1012580-19
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat the anastomosis from the saphenous vein grafts (svgs) to the mid left anterior descending (lad) coronary artery.A 6.0 fr non-abbott guide wire was used to engage the coronary artery and confirmed the lesion.Then, a non-abbott wire was placed and a 2.5x15mm unspecified balloon was used to pre dilate the lesion and a non-abbott intravascular lithotripsy (ivl) was used prior stenting.After 60 pulses and in the sixth dilatation inflated to 6 atmospheres, the angiography revealed a perforation in the lad.A 2.8x19mm graftmaster was attempted to be placed; however, after several attempts failed to cross since the non-abbott wire and non-abbott catheter extension did not provide sufficient support.The area clotted and a 2.0x12mm non-abbott balloon and a whisper wire replaced the other ones; however, they still could not cross.The patient became progressively unstable and had hypotension which was treated with fluids and medication.Pericardiocentesis was performed due to a pericardial effusion and the patient was sent for coronary artery bypass grafting (cabg) in order to seal the perforation as well as a surgical aortic valve replacement (savr) which was performed at the same time.The patient was hospitalized additional time.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.Na.
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 other incidents.The investigation determined the reported failure to advance and subsequent treatment with medication, surgical intervention, and unexpected medical intervention appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of surgical intervention and hypotension 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6; the code 4440 was deleted.
Event or Problem Description
Subsequent to the initially filed report, the account stated that the pericardial effusion was diagnosed via fluoroscopy and that a clot was not noted.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: 17378734
• Report Number: 2024168-2023-07880
• Device Sequence Number: 6302438
• Product Code: MAF
• UDI-Device Identifier: 08717648176357
• UDI-Public: 08717648176357
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 08/22/2023

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: 05/31/2024
• Device Catalogue Number: 1012580-19
• Device Lot Number: 2062041
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 109 KG