MAUDE Adverse Event Report: ABBOTT VASCULAR INC. GRAFTMASTER; CORONARY STENT DELIVERY SYSTEM

Model Number	1012581-19
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Shock (2072); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the mid left anterior descending (lad) coronary artery, which occurred post angioplasty and coronary lithotripsy.The 3.5x19 mm graftmaster covered stent was implanted at 15 atmospheres (atm) however the perforation was not sealed.The 3.5x26 mm graftmaster covered stent was implanted at 15 atm however there was still extravasation and the patient decompensated, went into shock and ultimately expired.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 device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined; however, the reported treatment appears to be related to operational context of the procedure.Additionally, the patient was declining in health towards death prior to use of the graftmaster stents.The physician stated that the graftmaster stents did not cause or contribute to the patient death.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem: updated.H6: health effect clinical code 2072 was removed and code 4582 was added.
Event or Problem Description
Subsequent to the initially filed report it was reported that both of the graftmaster devices had difficulty being placed in the correct position due to visibility issues.The stents were not implanted over the hole; therefore the perforation continued to leak.The patient was declining in health towards death prior to use of the graftmaster stents.The graftmaster stents did not cause any adverse patient effects.The physician stated that the graftmaster stents did not cause or contribute to the patient death.No additional information was provided.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 21358270
• Report Number: 2024168-2025-01530
• Device Sequence Number: 12882206
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: (01)08717648176401(17)250930(10)3102641
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/21/2025

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: 09/30/2025
• Device Model Number: 1012581-19
• Device Catalogue Number: 1012581-19
• Device Lot Number: 3102641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male