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

Model Number	1012582-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
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 reported patient effect of death, as listed in the graftmaster rx coronary stent graft system, instructions for use, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.In the physician's opinion, the use of the graftmaster did cause or contribute to the patient death in any way.The patient died due to pericardial hematoma and tamponade that led to cardiac arrest.The investigation was unable to determine a conclusive cause for the reported failure to seal.The reported patient effect of unrelated death was not associated to the use of the graftmaster and in the physician¿s opinion, was due to pericardial hematoma and tamponade that led to cardiac arrest.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 to treat a pin hole perforation in the proximal left anterior descending (plad) artery.The procedure was intravascular ultrasound (ivus) guided.Pre-dilation was performed with a 3.5mm non-compliant balloon, then a 3.5x12mm non-abbott stent was implanted and post dilatation was performed using a 4.0mm non-compliant balloon.A pin-hole perforation was then noted.The right common femoral vein was accessed and a 7french (fr) sheath was inserted, and tamponade occurred.Emergent pericardiocentesis was performed for the pericardial tamponade with autotransfusion via left femoral sheath.Patient became hemodynamically stable.A 4.0x16mm graftmaster covered stent was implanted at 15 atmospheres (atms); however, did not seal the perforation even though the correct size implant was used for the size of the perforation.There were no issues with deployment of the stent.The graftmaster did not exacerbate the existing perforation.The graftmaster did not cause or contribute to complications or adverse events.The patient died due to pericardial hematoma and tamponade that led to cardiac arrest.In the physician's opinion, the use of the graftmaster did cause or contribute to the 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: 16254119
• Report Number: 2024168-2023-00886
• Device Sequence Number: 20146051
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1012582-16
• Device Catalogue Number: 1012582-16
• Device Lot Number: 1052541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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 X 12MM DES; 6FR SHEATH; 7 FR SHEATH; INTRAVASCULAR ULTRASOUND (IVUS)
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 62 KG