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

Catalog Number	1012582-19
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
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 lesion in the circumflex (cx) artery.The 4.0x19mm graftmaster covered stent was advanced without resistance and was able to reach 20 atmospheres (atms) but would not hold the pressure.The stent was deployed with a couple of inflations at 20 atms, however, additional non-compliant balloons were used to post dilate the stent to achieve optimal results.The use of the graftmaster caused or contributed to complications or adverse event.However, the graftmaster delivery system was tested outside of the body and the balloon did hold the pressure and was working fine.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.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 identified no similar incidents from this lot.Furthermore, it was reported that the procedure was to treat a lesion in the circumflex (cx) artery.The 4.0x19mm graftmaster covered stent was advanced without resistance and was able to reach 20 atmospheres (atms) but would not hold the pressure.It should be noted 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 exceeded rated burst pressure contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported leak.The treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 18142331
• Report Number: 2024168-2023-12702
• Device Sequence Number: 7982654
• Product Code: MAF
• UDI-Device Identifier: 08717648176456
• UDI-Public: 08717648176456
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/01/2023

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: 1012582-19
• Device Lot Number: 2060241
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 82 KG