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

Model Number	1012582-19
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	09/14/2022
Type of Reportable Event	Death
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.Date estimated.
Event or Problem Description
It was reported that the procedure was to treat the saphenous vein graft to the obtuse marginal branch (om).Initially a run-through wire was passed into the om; however, an unspecified intravascular ultrasound (ivus) probe did not cross through the saphenous vein as significant calcification was noted and double layers of unspecified stents noted.A non-abbott balloon was attempted to be advanced, but also failed to cross; therefore, the decision was made to proceed with laser treatment.Three to four passes at 80s to 80 were performed and a 3.5x2mm non-compliant balloon was attempted to advance; however, failed.Shockwave balloon was used all at 80 pulses were given at the site and at the end it expanded; however, angiogram revealed a perforation of the vessel at the site of the shockwave therapy.The perforation was attempted to be treated with balloon dilatation, but failed and a 4.0x19mm graftmaster covered stent was deployed at 16 atmospheres (atm).Post dilatation with a 4.0mm non-compliant balloon was performed at 24 atms; however, the perforation did not seal.Surgery was consulted; however, it was noted to be extremely high risk and should try conservative therapy only.Balloon tamponade of the perforated site continued, but failed to seal the perforation.A second 4.5x15mm non-abbott covered stent was attempted to be advanced; however, became lost in the patient.The stent could not be located in the coronary artery or in the body scan.Therefore, a third 5x15mm non-abbott covered stent was advanced and deployed overlapping the graftmaster stent.Thrombus was noted to be forming in the graft.Patient began to experience chest pain, uneasiness and nausea.His blood pressure began to go down and was intubated, given medication.At this point the patient experienced multiple episodes of polymorphic ventricular tachycardia requiring multiple shocks.The vein graft completely closed, but a small posterior pericardial effusion was noted and attempts to aspirate the pericardial fluid was unsuccessful.Patient was shifted to the ccu on a ventilator noted to be in critical condition.The patient expired.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of death, thrombosis, tachycardia and hypotension are listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), as known patient effects 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 patient-device incompatibility/device operates differently (failure to seal)/stent graft leak.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatments 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 of the device.Na.

• 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: 15670459
• Report Number: 2024168-2022-11034
• Device Sequence Number: 6372599
• Product Code: MAF
• UDI-Device Identifier: 08717648176456
• UDI-Public: 08717648176456
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/15/2022

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: 05/31/2024
• Device Model Number: 1012582-19
• Device Catalogue Number: 1012582-19
• Device Lot Number: 2060241
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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: 4.0 NON-COMPLIANT BALLOON; 4.5X15MM PAPYRUS COVERED STENT; 5.0X15MM PAPYRUS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Male