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

Catalog Number	1012584-26
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Indication for use, incorrect anatomy and above rated burst pressure a jostent referenced is being filed under a separate medwatch report number.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.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, 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 greater than or equal to 2.75 mm in diameter.In addition, it was reported that the graftmaster was deployed between 19 and 20 atmospheres (atm).It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.The investigation was unable to determine a conclusive cause for the reported failure to seal the aneurysm; however, the reported treatment appears to be related to circumstances of the procedure.Based on the information reviewed, 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 patient has a fenestrated abdominal aortic stent graft that was previously placed in the past.Jostents were placed on (b)(6) 2011 in both renal arteries from the graft and in the celiac and superior mesenteric artery.A computed tomography scan in 2012 showed that the abdominal aortic stent graft was patent.The native abdominal aortic aneurysm was again observed and it decreased in size, measuring 6.9x6.3 cm.On (b)(6) 2016, the patient was admitted secondary to substernal chest pain.Reportedly, it appears that the jostent that was placed in the left renal artery has either developed a strut fracture or has developed migration outside of the graft where it was initially flared as it was implanted.That stent needs to be revised.Because of its size, the only available device would be an additional jostent.The patient has had significant enlargement of the abdominal aortic aneurysm as a result of this type 3 endoleak.On (b)(6) 2016, a 4.8x26 mm graftmaster stent was implanted in the left renal artery in an attempt to treat the endoleak; however, the stent graft did not seal the endoleak.Post-dilatation was performed; however, endoleak was still present.A non-abbott plug was used; however, the first time it was too far into the aortic area and it seemed to occlude the renal stent.The second time it flowered nicely.Brisk flow and no encroachment of the ostium was noted on angiography.The groin was perclosed and the patient was in stable condition.There was no clinically significant delay in the procedure.The patient was discharged in stable condition on (b)(6) 2016.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: 5988727
• Report Number: 2024168-2016-06537
• Device Sequence Number: 18848561
• Product Code: MAF
• UDI-Device Identifier: 08717648176524
• UDI-Public: (01)08717648176524(17)180131(10)6021641
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

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: 01/31/2018
• Device Catalogue Number: 1012584-26
• Device Lot Number: 6021641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 09/29/2016
• 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: STENT: JOSTENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 89