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

Model Number	1012580-19
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 99% stenosed lesion in the mid left anterior descending (mlad) artery.The patient presented with an active perforation and declining health.A 2.80x19mm graftmaster covered stent was advanced, however it failed to cross a previously implanted stent and could not reach the target lesion.A 2.80x16mm graftmaster covered stent was then advanced, however it also failed to cross the implanted stent and could not be implanted.The perforation was not sealed, and the patient expired on (b)(6) 2023.It was noted that the graftmaster covered stent did not cause or contribute to additional complications or adverse events.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned.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 determined the reported failure to advance appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The additional graftmaster device referenced in b5 is filed under separate medwatch report number.

• 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: 16833657
• Report Number: 2024168-2023-04448
• Device Sequence Number: 20628230
• Product Code: MAF
• UDI-Device Identifier: 08717648176357
• UDI-Public: 08717648176357
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/28/2023

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: 01/31/2024
• Device Model Number: 1012580-19
• Device Catalogue Number: 1012580-19
• Device Lot Number: 2021841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male