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

Model Number	1012582-26
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a large aneurysm in the saphenous vein graft to the right coronary artery.One 4.0 x 26 mm graftmaster stent was implanted at the distal arm of the aneurysm.Due to the size of the aneurysm, a second 4.0 x 26 mm graftmaster stent was implanted at the proximal aneurysm, overlapping the first.Filling was noted at the distal edge, so a 4.0 x 19 mm graftmaster was advanced through the two previously implanted stents.The stent was implanted and post dilatation was performed.No additional filling was noted.Haziness was noted at the proximal edge of the second 4.0 x 26 mm graftmaster stent, likely due to an edge dissection.A 3.5 x 12 mm non-abbott stent was implanted and the dissection was sealed.Post procedure, the patient was doing well.No additional information was noted.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of dissection is listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), as a known patient effect that may be associated with use of a coronary stent in native coronary arteries.It was reported that the procedure was performed to treat a large aneurysm in the saphenous vein graft to the right coronary artery.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, ifu states: the graftmaster rx 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 deviation directly caused or contributed to the reported event.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to circumstances 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
• MDR Report Key: 11402616
• Report Number: 2024168-2021-01656
• Device Sequence Number: 3483998
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Device Lot Number: 0112441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 73