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

Model Number ESBF2514C103E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Seroma (2069)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: etlw1613c124e sn (b)(4), expiration date: 2017-11-11, udi # (b)(4).

Event Description

An endurant stent graft system and six aptus endoanchors were implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.These were successfully deployed into the very proximal seal and appeared to have a good result.The delivery systems were removed and an angiogram performed, which showed a good result with no evidence of any type 1a endoleak or type 1b endoleak.There was no evidence of any late filling of the sac and good flow through the stented area.Therefore, the decision was made to complete the procedure.It was reported that during the closure of the left groin, the closure devices were tied down, but after the first two were tied down, two additional closures devices were used but there was a large amount of bleeding, therefore a cut down on the groin was performed.The physician followed the sheath and wire to the common femoral artery entrance site and saw that there was a large defect in the anterior wall of the common femoral artery.Once identified the proximal common femoral artery was clamped, then dissected distally and clamped across the distal common femoral as well.The arteriotomy was detected and debrided back the edges of the artery wall.It was observed that the hole in the vessel was from another manufacturer's closure device and could not be closed primarily, so a piece of bovine pericardium patch was sutured in place circumferentially with 5-0 prolene suture.Prior to completing the suture line appropriate flushing maneuvers were performed, restored antegrade flow and removed the clamps.At this point there was good flow which was confirmed by doppler, both proximally and distally and the patient was given 30 mg of protamine, and the soft tissue was closed with 3-0 vicryl suture and the skin was closed with staples.The patient was then extubated and transferred to the pacu for recovery.It was reported that the patient was re-admitted approximately three weeks later with left groin swelling.Groin exploration was performed and it was determined that the patient did not have an infection but did have a seroma/fluid collection which was found to have resolved while the patient was in for follow up.No additional clinical sequelae were reported and the patient is fine.

Event Description

Additional information received reported that the patient had left groin swelling and erythema.The investigator assessed this to be related to the index procedure.The patient was admitted to the hospital and the event resolved with treatment.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 6186329
• MDR Text Key: 62746548
• Report Number: 2953200-2016-02137
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439986
• UDI-Public: 00643169439986
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2018
• Device Model Number: ESBF2514C103E
• Device Catalogue Number: ESBF2514C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided; 02/17/2017
• Supplement Dates FDA Received: 03/13/2017; 09/27/2017
• Date Device Manufactured: 10/03/2016
• 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: 71 YR
• Patient Weight: 73