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

Catalog Number	1012582-16
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- medical device problem code 2017/above rbp.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a a very large perforation of a lesion in the proximal right coronary artery (prca).The 4.0x16mm graftmaster stent was implanted at 19 atmospheres (atms).The correct size implant was used for the perforation but failed to seal.Two other non-abbott covered stents were implanted but failed to seal as well.The patient health was already declining toward death as soon as the lesion perforated.The patient then went into asystole and cardiopulmonary resuscitation (cpr) was performed for 45 minutes but the patient died due to the perforation.In the opinion of the physician, the use of the graftmaster did not cause or contribute to patient's asystole or death in any way.No additional information was provided.
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 did not indicate a lot specific quality issue.It was reported that the graftmaster was deployed with a maximum pressure of 19 atmospheres (atm).It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use, specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.It is unknown if the ifu deviation contributed to the reported event.The reported patient effect of death, 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.The patient health was already declining toward death as soon as the lesion perforated.The patient then went into asystole and cardiopulmonary resuscitation (cpr) was performed for 45 minutes but the patient died due to the perforation.In the opinion of the physician, the use of the graftmaster did not cause or contribute to patient's asystole or death in any way.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak; however, the subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appears to be related to the operational context of the procedure.The reported patient effect of unrelated death was due to the perforation and not related to the device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 1762 removed; 4582 added.

• 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: 18389991
• Report Number: 2024168-2023-14429
• Device Sequence Number: 14121919
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/01/2024

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: 12/07/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/24/2023
• Supplement Report FDA Received Date: 02/01/2024
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG