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

Model Number	1012582-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
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 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 manufacture, design or labeling.The additional two graftmasters referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a free perforation located in the right coronary artery (rca).The 4.0x26mm graftmaster covered stent was attempted to be advanced and failed to cross due to the bulkiness of the stent.A second 4.0x16mm graftmaster covered stent was deployed to the same target lesion at 12 atmospheres (atms) and did not seal the perforation.A third 2.8x26mm graftmaster covered stent was deployed to the same target lesion at 14 atms, however, the stent would not expand to cover the perforation distally due to calcification and did not seal the perforation.The perforation appeared to be more proximal or mid vessel but involved distal area as well.The patient expired due to cardiogenic shock, coronary perforation and coronary artery disease.It was reported that the patient was declining towards death prior to use of the graftmaster stents and use of the graftmaster stents did not cause any adverse patient sequela.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: 13078423
• Report Number: 2024168-2021-12132
• Device Sequence Number: 4047979
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/23/2021

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: 01/31/2022
• Device Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Device Lot Number: 0020441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 84 KG