MAUDE Adverse Event Report: MEDTRONIC IRELAND TALENT - UNK; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number CV-SR-UNK-TALENT

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

Patient Problems Inflammation (1932); Renal Failure (2041)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; periaortite ¿de novo¿ após evar ou stenting do setor aorto-ilíaco: uma revisão sistemática mendes et al, angiology and vascular surgery / number 04 / volume 16 / december 2020 https://acvjournal.Com/index.Php/acv/article/download/356/218/.Exact date of implant unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

A talent stent graft was implanted during the endovascular treatment of an infrarenal aaa on an unknown date.It was reported approximately 17 months post the index procedure the patient presented with left-sided abdominal pain and unilateral hydronephrosis.A diagnosis of chronic peri-aortitis was confirmed.Treatment including a nephrectomy and commencement of tamoxifen was completed.The cause of the chronic peri-aortitis is undetermined.No additional clinical sequelae were reported and the patient will be monitored.

• Brand Name: TALENT - UNK
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12867664
• MDR Text Key: 281192826
• Report Number: 9612164-2021-04544
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P070027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2021

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: CV-SR-UNK-TALENT
• Device Catalogue Number: CV-SR-UNK-TALENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 11/24/2021
• 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: 59 YR
• Patient Sex: Male