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

Model Number UNK-CV-SR-VALIANT

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: midterm outcomes of primary and secondary use of an endoanchor system for thoracic and abdominal aortic endovascular aortic repair abdel-hadi et al, j vasc interv radiol 2023; 34:1938¿1945 https://doi.Org/10.1016/j.Jvir.2023.08.004 a2: mean age a3: mean gender d6a: exact date of implant unknown medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Heli-fx endoanchors were implanted in patients during primary and secondary procedures for prophylactic and intervention on unknown dates.One patient was treated with a valiant the following adverse events were reported: one patient with a valiant stent graft had endoanchors implanted due to loss of distal seal due to stent migration approximately 25 months post index procedure reuslting in a type ib endoleak.The cause of the migration and type ib endoleak are undetermined.

Manufacturer Narrative

Correction to aware date of complaint: updated to (b)(6) 2024.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 19190705
• MDR Text Key: 341128454
• Report Number: 9612164-2024-02005
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100040
• 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,Followup
• Report Date: 05/01/2024

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?: Yes
• 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: 04/24/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/01/2024
• 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: 79 YR