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

Model Number	1012581-19
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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.Medical device problem code 2017: above rbp.The additional devices referenced in b5 are captured under separate medwatch numbers.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the proximal left anterior descending (lad).A 3.5x19 mm graftmaster covered stent was implanted at 20 atmospheres (atm) and the perforation appeared sealed post stent placement.The patient was sent to the intensive care unit (icu) and they went into full arrest so the patient was brought back to the cath lab to re-evaluate the perforation.Blushing was seen so an impella pump was placed and the 4.0x19 mm graftmaster covered stent was implanted at 17 atm.The 4.5x19 mm graftmaster covered stent was implanted at 15 atm.Reportedly, the perforation appeared sealed post stent placement; however, the patient ultimately expired due to unspecified complications.The graftmaster devices reportedly did not cause or contribute to adverse events or complications.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed reports it was reported that the 4.5x19 mm graftmaster was deployed first.This did not completely seal the perforation and the 4.0x19 mm graftmaster was then implanted and the perforation was thought to have been sealed.The impella pump was placed due to high end diastolic pressure (edp).When the patient was brought back to the cath lab, the 3.5x19 mm graftmaster was deployed.In the physician's opinion, no graftmaster device caused or contributed to the patient death and the patient was declining in health (towards death) prior to use of the graftmaster devices.No additional information was provided.
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.Based on the information received, analysis will not be required as information received indicating there was no device malfunction.The investigation determined that the patient ultimately expired due to unspecified complications confirming the reported death not related to reported adverse event.The graftmaster device reportedly did not cause or contribute to adverse events or complications.In addition, it was reported that the graftmaster was deployed with a maximum pressure of 20 atmospheres (atm).It should be noted in the graftmaster instructions for use (ifu) specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.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.H6: correction health effect - clinical code 1762 was removed.H6: correction medical device problem code 2682 was removed.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY COVERED STENT
• 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23137750
• Report Number: 2024168-2025-10274
• Device Sequence Number: 18364914
• Product Code: NIV
• UDI-Device Identifier: 08717648176401
• UDI-Public: (01)08717648176401(17)261031(10)4112841
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012581-19
• Device Catalogue Number: 1012581-19
• Device Lot Number: 4112841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 81 KG