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

Catalog Number	1012580-19
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
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 procedure was to treat a 90% stenosis in the distal anastomosis of the saphenous vein graft (svg) to the diagonal as well as the native diagonal vessel through the graft.After pre-dilatation, a 2.0x10mm non-abbott cutting balloon dilatation was performed, which resulted in a significant vessel perforation.The perforation was tamponaded with an 8-minute inflation using a 2.0x30mm balloon; however the patient again developed recurrent chest pain; therefore the vessel was again tamponaded with the 2.0x30mm balloon while prepping a 2.8x19 mm graftmaster (gm) covered stent.It was realized that the stent was too large for the vessel, but it was to be inflated at very low pressure.However, the graftmaster would not go through the non-abbott support catheter which was being used for extra support.In the process of trying to remove the support catheter and prepare another graftmaster, the entire guide clotted off and the patient's chest pain had improved dramatically.A stat echocardiogram showed no significant pericardial effusion.So, at this point, it was thought that the graft to diagonal would likely clot off, therefore, no additional intervention was performed.The patient was to remain hospitalized overnight for monitoring.No additional information was provided.
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 was unable to determine a conclusive cause for the reported difficult to advance/position.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: 17375412
• Report Number: 2024168-2023-07869
• Device Sequence Number: 3784712
• Product Code: MAF
• UDI-Device Identifier: 08717648176357
• UDI-Public: 08717648176357
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 1012580-19
• Device Lot Number: 2032241
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/22/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER, PROWATER GUIDE WIRE
• Patient Age: 64 YR
• Patient Sex: Female