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

Model Number UNK-CV-SR-ENDURANT

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Renal Failure (2041); Seroma (2069); Claudication (2550)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; midterm single-center results of endovascular aneurysm repair with additional endoanchors sekub r.Goudeketting, jan wille, daniel a.F, van den heuvel, jan-albert vos, jean-paul p.M.De vries department of vascular surgery, st antonius hospital, nieuwegein, the netherlands mira institute of biomedical technology and technical medicine, university of twente, enschede, the netherlands department of interventional radiology, st antonius hospital, nieuwegein, the netherlands department of vascular surgery, university medical centre groningen, the netherlands https://doi.Org/10.1177/1526602818816099; 18 against ifu due to use in short neck anatomy.If information is provided in the future, a supplemental report will be issued.

Event Description

Heli-fx guide, applier and endoanchors were used prophylactically and therapeutically in the endovascular treatment of patients in conjunction with endurant, valiant and talent stent grafts.The following adverse events were noted; serious injury; icu hospitalisation, rupture, explant, infection, reintervention, surgical conversion, renal dysfunction, hematoma, claudication, seroma.

• Brand Name: ENDURANT
• 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: 8361079
• MDR Text Key: 136846228
• Report Number: 2953200-2019-00252
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2019

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: UNK-CV-SR-ENDURANT
• Device Catalogue Number: UNK-CV-SR-ENDURANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/22/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 75 YR