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

Model Number	1012580-16
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Pericardial Effusion (3271)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the distal left anterior descending artery observed via angiogram after two (2.5x8mm and 2.0x15mm) non-abbott stents had been implanted.Post dilatation was performed at the overlap of the stents and the balloon was re-advanced to tamponade the segment as echo showed only trace effusion without tamponade.A 2.8x16mm graftmaster covered stent was attempted to be advanced pass the previously implanted stents; however, became stuck with the stents.During removal the shaft separated as the device was stuck resulting in a complete occlusion of the mid lad.Multiple attempts were made to snare and balloon trap the separated portion; however, resulted unsuccessful.During this time the patient became hypotensive with st segment elevation requiring medication.Finally a 1.2x8mm mini trek balloon was attempted to be advanced adjacent to crush the stent; however, was unable to pass the occlusive stent.A wire was advanced into the pericardial space followed by serial dilatation and placement of a 9f pericardial drain.Fluid was remove with trace residual effusion by tte.The drain was sutured in placed and reservoir bag attached.The separated portion remains in the anatomy; however, it was noted the patient tolerated the procedure well with no immediate complications.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Subsequently, after the initial report was filed, the account stated the graftmaster also met resistance with anatomy during removal.The separated portion remained stuck in the stented segments of the lad.The perforation was noted to be sealed by the occlusion that occurred no other stent was used to seal the perforation.It was noted an acute myocardial infraction was also due to the use of the graftmaster.The mini trek failed to cross due to the anatomy (occlusion).A clinically significant delay was reported.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 investigation determined the reported difficulties and subsequent foreign body in patient, treatment with medication, delay to treatment, and unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effects of myocardial infarction, occlusion, and hypotension as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), are 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.

• 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: 17079388
• Report Number: 2024168-2023-06003
• Device Sequence Number: 2188062
• Product Code: MAF
• UDI-Device Identifier: 08717648176340
• UDI-Public: 08717648176340
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 08/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1012580-16
• Device Catalogue Number: 1012580-16
• Device Lot Number: 2011741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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: 2.0X15MM ONYX FRONTIER; 2.5X38MM ONYX FRONTIER
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 44 KG