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

Model Number	1012581-19
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Nausea (1970); Pain (1994); Tachycardia (2095)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left anterior descending (lad) coronary artery that occurred after stenting with a non-abbott 3.5x26 mm drug eluting stent.A non-abbott stent was deployed and serial post dilatation was performed but there was continued bleeding.The patient began experiencing hypotension despite fluid boluses.Norepinephrine was provided and pericardiocentesis was performed with echocardiography confirming a rapidly deploying effusion with right ventricle collapse consistent with cardiac tamponade.Before placement of the pericardial drain, an agitated saline study was performed confirming location and the 3.5x19 mm graftmaster covered stent was deployed at 15 atmospheres.This stent did not seal the perforation so a 4.0x19 mm graftmaster covered stent was deployed at 15 atmospheres overlapping the first graftmaster.Despite multiple inflations the bleeding continued and inflation was performed with a 4.0 mm nc non-abbott balloon for 30 second episodes.There were two episodes of polymorphic ventricular tachycardia and electrical cardioversion was performed.The patient was struggling with dyspnea, discomfort and nausea.After repeated inflations the bleeding was noted to have stopped.After 1 hour, repeated bedside echocardiography confirmed no pericardial effusion.The patient was transferred to cardiac care unit for further management and was discharged to a subacute rehab center on july 5, 2025.The patient has been followed up as an outpatient and is doing well.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.

• 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 25627337
• Report Number: 2024168-2026-02527
• Device Sequence Number: 15728710
• Product Code: NIV
• UDI-Device Identifier: 08717648176401
• UDI-Public: (01)08717648176401(17)250930(10)3102641
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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 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): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/25/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.0X19 MM GRAFTMASTER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White