MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ETBF2813C166E

Device Problems Leak/Splash (1354); Inaccurate Delivery (2339)

Patient Problem Occlusion (1984)

Event Date 01/28/2014

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of a 5.2cm abdominal aortic aneurysm.Aneurysm and vessel morphology was reported as the proximal neck diameter was 23mm and 15mm in length.During the initial discussion prior to the procedure, the physician discussed the possibility to place the main body via left side; however, a review of the film gave the impression that the length was 160mm on the right side and the device would foreshorten through tortuosity; therefore, the physician decided the right side instead.During the index procedure the main body landed 5mm below the left lowest renal artery resulting in a slight type ia endoleak.The physician added a 28 cuff and the endoleak was resolved.It was also noted that the physician inadvertently covered the right hypo due to a combination of landing a bit low and the length was closer to 150mm.The cause for the inaccurate delivery is unknown.No intervention has been planned.No additional clinical sequelae were reported and the patient will be monitored by the physician.

Manufacturer Narrative

(b)(4).Results and conclusion: (endoleak, inaccurate delivery, occlusion).(cause is unknown).

• Brand Name: ENDURANT II
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3638160
• MDR Text Key: 3988846
• Report Number: 2953200-2014-00307
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2015
• Device Catalogue Number: ETBF2813C166E
• Device Lot Number: V04120468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Date Device Manufactured: 09/24/2013
• 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): Required Intervention
• Patient Age: 00080 YR