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

Catalog Number ETCF2525C49E

Device Problem Inaccurate Delivery (2339)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/04/2014

Event Type  Injury  

Event Description

An endurant stent graft was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.The aneurysm at time of implant was reported to be 77.8 mm in size.It was reported that approximately five years post index procedure a follow-up ct scan indicated that the patient¿s aneurysm had continued to enlarge.The physician noted that the patient has a type ii endoleak ima embolization with sac coils.There was no evident endoleak or migration seen; however, the physician also noted the possibility of a potential type iii (fabric) endoleak.The physician decided to add an endurant cuff 25x25 on the proximal side and realign the limbs with a 16x93 on the right side and 16x124 on the left.The physician deployed the cuff and attempted to shorten it slightly with proximal pressure on the delivery handle; however, the cuff partially covered the left renal.The physician is not planning additional treatment since the renal artery is small in diameter and poorly functioning prior to the intervention.The type iii endoleak resolved after the intervention.The type ii endoleak was left unresolved.No additional clinical sequelae were reported and the patient will be monitored by the physician.

Manufacturer Narrative

(b)(4): evaluation, results: inherent risk of procedure (occlusion).Patient¿s condition affected effectiveness of device (anatomy related; type ii endoleak).Incorrect technique/procedure (user related).Conclusions: inherent risk of a procedure (occlusion).Device failure/lack of effectiveness related to patient condition (anatomy related; type ii endoleak).

• 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: 3667882
• MDR Text Key: 16799109
• Report Number: 2953200-2014-00393
• 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: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2015
• Device Catalogue Number: ETCF2525C49E
• Device Lot Number: V04110697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Date Device Manufactured: 09/04/2013
• 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: 00092 YR
• Patient Weight: 77