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

Model Number UNK-CV-SR

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

Patient Problems Stroke/CVA (1770); Ischemia (1942); Myocardial Infarction (1969); Paralysis (1997); Renal Failure (2041); Respiratory Failure (2484); Vascular Dissection (3160)

Event Date 12/23/2022

Event Type  Injury  

Event Description

Medtronic stent grafts (unknown bramd) were implanted during the endovascular treatments of tbad on unknown dates.The following adverse events were reported: stroke, spinal cord ischemia, mi, acute kidney injury, cardio-respiratory failure, resp iratory failure, paralysis, left arm ischemia, disease progression and reintervention.The cause of the adverse events are undetermined.

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: ethnic <(>&<)> sex disparities in type b aortic dissection patients undergoing thoracic endovascular aortic repair: an international perspective bashir et al, ann vasc surg 2023;94: 68¿79 https://doi.Org/10.1016/j.Avsg.2022.12.073 a2: mean age a3: mean gender d6a: exact date of implant unknown date of publish used for incident date in section b;3 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: UNK-CV-SR
• 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: 19212167
• MDR Text Key: 341369125
• Report Number: 9612164-2024-02057
• 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
• Report Date: 04/30/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR
• Device Catalogue Number: UNK-CV-SR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/30/2024
• 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 Age: 61 YR
• Patient Sex: Male