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

Catalog Number	1012581-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left circumflex (lcx) artery.The first 2 graftmaster covered stents, both 2.8x16mm, were the correct sizes implanted but failed to seal the perforation due to the perforation being larger than anticipated.A third and fourth graftmaster covered stent of the same size, 3.5x16mm, which were larger since a smaller size was not available in the lab were also implanted, however, still failed to seal exacerbating the existing perforation.The perforation was ultimately sealed by reversing the anti-coagulation meds and inflating a balloon in the distal lm-proximal lcx for intentional thrombus formation to tamponade the distal left main (lm) to the lcx artery.There was no clinically significant delay in the procedure.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.The additional 3.5x16mm graftmaster device referenced in b5 is filed under a separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left circumflex (lcx) artery.The first 2 graftmaster covered stents, both 2.8x16mm, were the correct sizes implanted but failed to seal the perforation due to the perforation being larger than anticipated.A third and fourth graftmaster covered stent of the same size, 3.5x16mm, which were larger since a smaller size was not available in the lab were also implanted, however, still failed to seal exacerbating the existing perforation.The perforation was ultimately sealed by reversing the anti-coagulation meds in order for thrombus formation to form from the distal left main (lm) to the lcx.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: intentional thrombus formation after balloon inserted in distal lm-proximal lcx and inflated to tamponade the cx vessel.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.The reported patient effect of perforation, as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.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 treatment appears to be related to the operational context of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• 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: 17603455
• Report Number: 2024168-2023-08821
• Device Sequence Number: 6308184
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: 08717648176395
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/11/2023

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: 10/31/2023
• Device Catalogue Number: 1012581-16
• Device Lot Number: 1112241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2 - 3.5X16MM GRAFTMASTER STENTS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 77 KG