MAUDE Adverse Event Report: AV-TEMECULA-CT JOSTENT GRAFTMASTER; CORONARY STENT GRAFT

Device Problems Break (1069); Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Aneurysm (1708); Angina (1710); Dyspnea (1816); Fatigue (1849); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Diaphoresis (2452); Test Result (2695)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional graftmaster referenced is being filed under separate medwatch reports.

Event 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.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The investigation was unable to determine a conclusive cause for the reported stent fracture and stent migration.The reported material deformation (flared stent) appears to be due to circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, could not be determined; however, the reported treatments appear to be related to the circumstances of the procedure.It should be noted that the jostent graftmaster over the wire (otw), instructions for use states: the jostent graftmaster is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of coronary artery aneurysm, coronary bypass-vein graft aneurysm, acute coronary artery perforation and/or acute coronary artery rupture.Patients being considered for stent implantation should be acceptable candidates for coronary artery bypass graft surgery, and/or for coronary balloon angioplasty with ischemic heart disease due to discrete de novo or restenotic native coronary lesions.The reported patient effects of angina, aneurysm, hemorrhage and hypertension as listed in the jostent graftmaster otw ifu, are known patient effects that may be associated with use of a coronary stent in native coronary arteries.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.

• Brand Name: JOSTENT GRAFTMASTER
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5944060
• MDR Text Key: 54506450
• Report Number: 2024168-2016-06030
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 89