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

Model Number	1012582-26
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional graftmaster device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the saphenous vein graft that was noted after stenting with a 3.5x38 mm non-abbott stent.The 4.0x26 mm graftmaster covered stent was advanced over the wire and into the proximal vein graft; however, there was significant resistance and the stent could not cross to treat the perforation.During removal there was resistance when pulling the grastmaster into the guiding catheter.During this time, dopamine infusion was started, a periocardiocentesis tray was opened and echocardiogram performed suggested there was not significant effusion.Next, a 3.5x20 mm non-abbott stent was inserted into the vein graft and inflated, and angiogram showed persistent active extravasation of dye.The balloon was removed and a 6fr guideliner was inserted to assist with delivery of the 4.0x19 mm graftmaster; however, it was not able to cross to treat the perforation.The patient was sent to surgery and the patient expired.No additional information was provided.
Event or Problem Description
Additional information received indicates that the graftmaster devices were unable to be delivered due to the anatomy.The patient was unable to undergo emergent surgery and after 30 minutes of chest compressions, the patient expired.In the opinion of the physician, the graftmaster devices did not cause or contribute to the patient death.The patient was in declining health (toward death) prior to use of the graftmaster stents.The ultimate cause of death was cardiac tamponade, hypotension and cardiac failure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported failure to advance, difficult to remove and subsequent treatments appear to be related to the operational context of the procedure.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 the design, manufacture or labeling of the device.B2: outcomes attributed to ae.H1: type of reportable event.H6: patient code 1802 removed.

• 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: 10038978
• Report Number: 2024168-2020-04189
• Device Sequence Number: 2553539
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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 Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROMUS PREMIER 3.5 X 38 MM; PROMUS PREMIER 3.5 X 38 MM
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 64