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

Catalog Number	1012582-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional graftmaster device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the patient was experiencing a non st elevated myocardial infarction (nstemi) and during coronary angioplasty a described severe perforation occurred in the left anterior descending (lad) coronary artery that would require at least three covered stents.Anatomical history of the vessel includes a significantly small diameter, complete total occlusion with pre-dilation performed with an unspecified 2.0x30 balloon dilating catheter.Three graftmaster covered stents (2.8x16mm, 2.8x26mm, 3.5x26mm) were successfully implanted and each sealed the specific area in the lad.However, the perforation was still larger than expected and a 3.5x26mm graftmaster was advanced, inflated to an unknown pressure, but would not deploy.Under fluoroscopy, the graftmaster was noted to be fractured on the delivery system but not in two pieces.The delivery system with the stent attached and the guiding catheter were removed from the anatomy intact as a single unit under fluoroscopy with no resistance.A 4.0x26mm graftmaster covered stent which was attempted to advance to the lesion site, but the stent size was deemed too large for the small vessel thus failed to cross due to anatomy.A non-abbott 3.5x26 covered stent was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.The patient was discharged home the next day with no issues.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: 19154990
• Report Number: 2024168-2024-04933
• Device Sequence Number: 7862425
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: (01)08717648176463(17)250430(10)3052541
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/22/2024

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: 04/30/2025
• Device Catalogue Number: 1012582-26
• Device Lot Number: 3052541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.8X16MM, 2.8X26MM, 3.5X26MM GRAFTMASTER STENTS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White