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

Model Number	1012584-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation (2001)
Date of Event	05/11/2021
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 identified no other incidents.The reported patient effect of death as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.In the opinion of the physician, the use of the graftmaster did not cause or contribute to the patient death in any way.The patient's health was declining toward death and the physician reported that cardiac arrest was ultimately the cause of patient death.The investigation was unable to determine a conclusive cause for the reported failure to seal.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other graftmaster is filed under a different medwatch mfr number.
Event or Problem Description
It was reported that patient presented in declining health.During a coronary intervention, a large perforation occurred in the saphenous vein graft (svg).A 4.8x16mm rx graftmaster covered stent was advanced to the perforation and deployed at 15 atmospheres (atm) but was deployed too proximal in the perforation and did not seal the perforation.A 4.0x16mm rx graftmaster, was then advanced and deployed at 15 atm but the perforation failed to seal.At some point post procedure, the patient went into cardiac arrest and died.In the opinion of the physician, the use of the graftmaster stents did not 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
• MDR Report Key: 11939766
• Report Number: 2024168-2021-04669
• Device Sequence Number: 1061256
• Product Code: MAF
• UDI-Device Identifier: 08717648176500
• UDI-Public: 08717648176500
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: 10/31/2022
• Device Model Number: 1012584-16
• Device Catalogue Number: 1012584-16
• Device Lot Number: 0112641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Weight: 68