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

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

Patient Problems Stroke/CVA (1770); Ischemia (1942); Pain (1994); Paralysis (1997); Rupture (2208); Stenosis (2263); Vascular Dissection (3160)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: management of left subclavian artery in type b aortic dissection treated with thoracic endovascular aorta repair wang et al, journal of vascular surgery, volume 77, issue 5, p1553-1561.E2, doi:https://doi.Org/10.1016/j.Jvs.2022.10.013 a2: mean age a3: mean gender d6a: exact date of implant unknown date of publish used for incident date in section b;3 there was no information to suggest any medtronic device failure caused or contributed to a death.Deaths are common occurrences however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable as mdr unless clearly stated as being associated with medtronic product.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

Medtronic stent grafts (unknown type) were implanted during the endovascular treatment of type b thoracic aortic dissections on unknown dates.Non medtronic grafts were also used.The following adverse events were reported: dissection, steal syndrome, left arm claudication.Stroke, paraplegia, spinal cord ischemia, aortic rupture, reintervention and death.The cause of the adverse events are undetermined.There was no information to suggest any medtronic device failure caused or contrib uted to a death.

• 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: 19212302
• MDR Text Key: 341372685
• Report Number: 9612164-2024-02060
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2024
• Initial Date FDA Received: 04/30/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR