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

Catalog Number	1012581-19
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 3.5x19mm graftmaster covered stent was implanted and sealed a perforation in an unspecified artery; however, a perforation of the saphenous vein graft (svg) occurred.There was no report of treatment or adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Correction: b2 - outcomes attributed to ae updated from "other serious" to "n/a".H6: health effect - clinical code 2135 was removed and code 4582 was added.H6: health effect - impact code 4614 was removed and code 2199 was added.H6: medical device problem code 2993 was removed and code 3189 was added.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.A review of the complaint history was not performed because the failure mode was not specified.The investigation was unable to determine a conclusive cause for the reported difficulties as a failure mode was not reported and there were no reported adverse patient effects.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
Subsequent to the initially filed mdr report.Information was received, indicating that the graftmaster was implanted without issue to seal a perforation in the saphenous vein graft (svg).There were no reported adverse patient effects.Although the graftmaster stent did not cause or contribute to the perforation, this event has been reported; therefore, it will remain reportable.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: 18732016
• Report Number: 2024168-2024-02008
• Device Sequence Number: 6349478
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: (01)08717648176401(17)240531(10)2060141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/09/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 1012581-19
• Device Lot Number: 2060141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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 Age: 71 YR
• Patient Sex: Male