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

Model Number	1012581-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Edema (2020); Cardiogenic Shock (2262); Thrombosis/Thrombus (4440)
Date of Event	04/14/2023
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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of death and thrombosis are listed in the graftmaster rx coronary stent graft system, instructions for use as known patient effects that may be associated with use of a coronary stent in native coronary arteries.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid left anterior descending (mlad) coronary artery with heavy tortuosity and 99% stenosis.A 6fr sheath was introduced and two non-abbott catheters were used to performed the angiogram.A whisper guide wire was advanced but failed to cross the lesion.Two non-abbott guide wires were advanced with resistance in the anatomy.Angioplasty was performed with a 2.5x15 unspecified balloon and a 3.5x18mm non-abbott stent was implanted in the proximal portion of the bend to straighten the tortuosity.Following this, balloon angioplasty was performed with a non-compliant (nc) balloon and a 3.5x12mm non-abbott stent was placed.Post-procedure angiogram showed a perforation with a drop in heart rate and blood pressure.During a stat echocardiogram, a cardiac tamponade was noted and a pericardiocentesis was performed successfully.A 3.50x16mm graftmaster was used to sealed the perforation.Following the pericardiocentesis and placement of the gratmaster stent, the blood pressure and heart rate improved.After the procedure the patient was stabilized and extubated but developed a thrombosis inside the graftmaster.An emergent percutaneous coronary intervention (pci) was performed in the mlad.Unspecified drug eluting stents were used, reducing the stenosis to 0% and a 2 timi score flow during an aspiration thrombectomy with a non-abbott catheter.On (b)(6) 2023, the patient died due to a cardiogenic shock with pulmonary edema.The physician stated the graftmaster covered stent did not cause or contribute to the patient death.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: 16919790
• Report Number: 2024168-2023-05110
• Device Sequence Number: 6910799
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: 08717648176395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1012581-16
• Device Catalogue Number: 1012581-16
• Device Lot Number: 2021741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: 3.5 EBU GUIDE WIRE.; CHOICE FLOPPY GUIDE WIRE.; UNSPECIFIED NON-COMPLIANT BALLOON.; WHISPER WIRE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female