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 Codes	Cardiac Arrest (1762); Extravasation (1842); Perforation (2001); Tachycardia (2095); Pericardial Effusion (3271)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information the 3.5x16mm graftmaster stent referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that during an intervention to the left anterior descending coronary artery, a perforation occurred from a non-abbott device.A 4x16mm graftmaster stent was implanted, followed by post-dilatation with a non-abbott balloon, with continued extravasation as the graftmaster stent did not seal the perforation.While waiting for an additional covered stent, a non-abbott des was then rapidly advanced to the distal lad, overlapping with the distal edge of the 3x28mm non-abbott des and deployed.A 2nd non-abbott wire was advanced into the lad to recanalize the diagonal 2 artery, and a perforation occurred.A 3.5x16mm graftmaster covered stent was placed at the site of the perforation and deployed at nominal pressure.At this time the patient was noted to be in pulseless electrical activity (pea) arrest and a small to moderate pericardial effusion was noted.Cardiopulmonary resuscitation (cpr) was immediately started along with medications administered but the patient went into ventricle tachycardia and defibrillation was performed.The bleeding continued and the patient expired on (b)(6) 2022.Per the physician, the use of the graftmaster devices did not cause additional complications or adverse events.No additional information was provided.
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.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; however, the physician reported that the use of the graftmaster devices did not cause the unrelated death.The subsequent treatment appear 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.

• 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: 15374068
• Report Number: 2024168-2022-09470
• Device Sequence Number: 17488603
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 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: 08/18/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/28/2022
• 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: PK F'APYRUS 4.5 X 16 MM COWRED . STENT; PK PAPYRUS 3.0 X 20 MM CO\ELRED STENT; PK PAPYRUS 3.0 X 20 MM CO\ERED STENT; PK PAPYRUS 4.0 X 20 MM COVERED STENT,; PK PAPYRUS 4.5 X 20 MM COVARED STENT; SYNERGY :XO 3.0 X 20 MM DRUG-ELUTING STENT; SYNERGY MEGA1RON; SYNERGY MEGA1RON 3.5 X 32; SYNERGY XD 3.0 X 28 MM DRUG-ELUTING STENT; XO STENTS OF A PK PAPYRUS 4.0 X 15 MM CO\ERED STEN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female