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

Catalog Number	1012581-19
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional graftmaster devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a perforation of a lesion in the mid left anterior descending (mlad) artery.Rotational atherectomy was performed in the mid lad.A 6french (f) guide catheter was advanced via the radial sheath.A whisper guide wire advanced into the large diagonal.A 2.0x12mm over-the-wire (otw) balloon was advanced over the rotational atherectomy wire and used to exchange for a long whisper wire.Flow into the diagonal was compromised and attempted to wire the diagonal using a whisper wire without success due to the anatomy.Eventually resulted in a perforation.A 2.5x38mm non-abbott stent was implanted but perforation persisted.The 3.0x26mm non-abbott stent was implanted but despite efforts at balloon tamponade perforation persisted.The first 2.8x19mm graftmaster covered stent was implanted but could not be delivered distally due to vessel tortuosity and rigid nature of the covered stent.Multiple balloon inflations were performed hoping to obtain adequate hemostasis without success.Unclear if there was a leak in the initial stent.A second 2.8x19mm graftmaster covered stent was implanted at the mid portion but attempted to implant distally but could not get the stent to pass first 2.8x19mm, however, perforation persisted.Another 3.5x19mm graftmaster covered stent was implanted at the proximal but still did not seal the perforation.Multiple balloon inflations were performed after heparin reversal without resolution.At this point there were no other viable options.Patient continued to decline from a hemodynamic standpoint and further interventions were deemed futile.The patient died.Autopsy was not performed.The cause of death was cardiac tamponade, perforation, and cardiogenic shock.In the opinion of the physician, the 3 graftmasters did not cause or contribute to the cardiac tamponade, cardiogenic shock and patient death in any way.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: 18748055
• Report Number: 2024168-2024-02144
• Device Sequence Number: 6271593
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: 08717648176401
• 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
• Device Implanted Year: 2024
• 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): 02/21/2024

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: 02/29/2024
• Device Catalogue Number: 1012581-19
• Device Lot Number: 2032341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: 2.8X19MM GRAFTMASTER STENT; 6FR GUIDE CATHETER; 7F GUIDELINER; ROTAFLOPPY WIRE; WHISPER GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 54 KG