MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number	1012584-26
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use (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.The ifu also states: fully expand the stent graft by inflating to nominal pressure at a minimum, which is 15 atmospheres.The reported patient effect of stenosis is also a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effect(s), 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 the procedure was to treat a high cervical internal carotid artery with flow limiting stenosis and brain hypoperfusion with associated larger growing pseudoaneurysm.The 4.80x26 graftmaster stent was deployed at 12 atmospheres.The pseudoaneurysm was excluded and normal luminal diameter was restored and brain perfusion was improved.The patient was discharged home with medication.There was no adverse patient sequela.Additional information received noted that after implantation of the graftmaster stent, an indentation of the carotid was noted a few cm above the stent.This has no responded to the administration of intravenous nitroglycerin.There is persistent stenosis for a few cm above the newly placed stent.A precise self expandable 5 x 30 mm stent was then advanced over the wire and distal to the covered stent to cover the stenotic segment.Follow up angiography reveals restoration of the normal luminal diameter of the artery and complete exclusion of the pseudoaneurysm.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7274474
• Report Number: 2024168-2018-01141
• Device Sequence Number: 1044526
• Product Code: MAF
• UDI-Device Identifier: 08717648176524
• UDI-Public: 08717648176524
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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: 04/30/2019
• Device Catalogue Number: 1012584-26
• Device Lot Number: 7051841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/15/2018
• 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: 34 YR