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

Model Number ETCF2323C49EE

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

Patient Problems Hematoma (1884); Seroma (2069); Swelling (2091); Injury (2348)

Event Date 07/21/2014

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: etcf2525c49ee continued from (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient received two endurant cuffs and 10 endoanchors due to a type ia endoleak.It was reported that approximately seven weeks later the patient experienced a right groin hematoma/seroma.The patient was hospitalized and released four days later and the event was unresolved without treatment.Per the investigator, the cause of the event related to the index procedure.No additional clinical sequelae were reported and the patient exited the study approximately 3 months later due to overall medical condition.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7817708
• MDR Text Key: 118270746
• Report Number: 2953200-2018-01216
• 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,Followup
• Report Date: 11/21/2018

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: ETCF2323C49EE
• Device Catalogue Number: ETCF2323C49EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 11/21/2018
• 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): Hospitalization
• Patient Age: 83 YR
• Patient Weight: 57