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

Model Number	1012584-19
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/19/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Date of death: estimated.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 did not indicate a lot specific quality issue.The reported patient effect of death is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use (ifu), as a known patient effect of coronary stenting procedures.It was reported that the procedure was performed to treat a pseudoaneurysm in the proper hepatic artery.It should be noted that the ifu states: the device is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts.It is unknown if the ifu deviations contributed to the reported event.The investigation determined the reported failure to advance appears to be related to circumstances 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.
Event or Problem Description
It was reported that the procedure was performed to treat a pseudoaneurysm of the proper hepatic artery, which was bleeding and was caused by a traumatic injury.Unspecified treatment was performed, but did not seal the bleed.Using a graftmaster stent was the last option, so the 4.8 x 19 mm graftmaster stent system was advanced into the anatomy, but was unable to cross to the target location due to the patient anatomy.The device was removed without issue and no additional treatment was performed at that time.Per physician, the graftmaster stent did not cause or contribute to worsening of the hepatic bleed.One day later, the patient underwent a second procedure to treat the hepatic artery pseudoaneurysm and a non-abbott stent was implanted successfully sealing the pseudoaneurysm.Approximately two days post procedure, the patient died of causes related to the hepatic bleed.No additional information was provided.
Additional Manufacturer Narrative
Abbott vascular medical affairs reviewed the reported information and concluded that the cause of death was due to hepatic bleed from a pseudoaneurysm of the hepatic artery.Graftmaster was used as an off-label and did not cause or contribute to the patient¿s death.The investigation determined the cause of death was due to hepatic bleed from a pseudoaneurysm of the hepatic artery.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9718133
• Report Number: 2024168-2020-01554
• Device Sequence Number: 11675103
• Product Code: MAF
• UDI-Device Identifier: 08717648176517
• UDI-Public: 08717648176517
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/18/2020

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 Expiration Date: 07/31/2020
• Device Model Number: 1012584-19
• Device Catalogue Number: 1012584-19
• Device Lot Number: 8082041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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: Death
• Patient Age: 69 YR