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

Model Number ETCF2525C49EE

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

Patient Problems Anemia (1706); Fatigue (1849); Weakness (2145); Ambulation Difficulties (2544)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: e tcf2323c49ee, s/n: unknown; use by date: unknown; upn # unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An aneurx stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported approx.7 years, 8 months post index procedure, intervention was completed for a type ia endoleak where two endurant cuffs and 10 endoanchors were implanted in the 32mm aaa.The endoleak was resolved post implantation.On the same date the patient was diagnosed with anemia with a low hemoglobin.Prolonged hospitalization and a blood transfusion was administered which resolved the event and the patient was discharged to a nursing home 5 days later.The following day, the patient presented to hospital with pancytopenia and symptoms of reduced mobility.The patient received a blood transfusion and was discharged after 2 days.Four days later, the patient again presented to hospital with anemia and associated symptoms of fatigue and weakness.The patient received a blood transfusion and the event was resolved.The investigator assessed the event as not related to the device or procedure.Per the sponsor, the event is causally related to the index procedure.No additional clinical sequelae were reported.

• Brand Name: ENDURANT II EXTENSION CUFF
• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7812336
• MDR Text Key: 118097198
• Report Number: 2953200-2018-01211
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2018

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 Model Number: ETCF2525C49EE
• Device Catalogue Number: ETCF2525C49EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/24/2018
• 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: 83 YR
• Patient Weight: 57