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

Model Number UNK-CV-SR-VALIANT

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

Patient Problems Intimal Dissection (1333); Aneurysm (1708); Rupture (2208)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; preoperative distal aortic diameter is a significant predictor of late aorta-related events after endovascular repair for chronic type b aortic dissection oishi y, yamashita y, kimura s, sonoda h, matsuyama s, ushijima t, fujita s, tatewaki h, tanoue y, shiose a.General thoracic and cardiovascular surgery (2020) 68:1086¿1093 https://doi.Org/10.1007/s11748-020-01318-1.If information is provided in the future, a supplemental report will be issued.

Event Description

Valiant stent grafts and non mdt stent grafts were implanted in the endovascular treatment of for chronic type b aortic dissection <(>&<)> thoracic aortic aneurysms.The following malfunctions were observed; type ii endoleak, unknown endoleak the following adverse events were observed; rupture, aneurysm enlargement, rtad, sine, re-intervention.Patient deaths were reported but there is no causal link that the valiant stent grafts caused or contributed to these deaths.

• Brand Name: VALIANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; IE ; 091708096
• MDR Report Key: 10745940
• MDR Text Key: 213369076
• Report Number: 9612164-2020-04099
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• 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: 10/28/2020

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-VALIANT
• Device Catalogue Number: UNK-CV-SR-VALIANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR