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 Arrhythmia (1721); Stroke/CVA (1770); Hematoma (1884); Ischemia (1942); Myocardial Infarction (1969); Pneumonia (2011); Renal Failure (2041); Obstruction/Occlusion (2422)

Event Date 06/18/2021

Event Type  Injury  

Event Description

Unknown medtronic stent grafts were implanted in patients during the endovascular tevar with laser in situ fenestration (lisf) on unknown dates.Non mdt stent grafts were also implanted.The following adverse events were reported: bypass stenosis stroke, spinal cord ischemia, access site hematoma, arrhythmias, aki, pneumonia, thoracic duct injury, mi, reintervention and death.There was no information to suggest any medtronic device failure caused or contributed to a death.The cause of the adverseevents are undetermined.

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; laser in situ fenestration in thoracic endovascular aortic repair: a single-center analysis evans et al, ann vasc surg 2021; 76: 159¿167 https://doi.Org/10.1016/j.Avsg.2021.05.006: mean age, mean gender, and exact date of implant unknown.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 or vigilance unless clearly stated as being associated with medtronic product.If information is provided in the future, a supplemental report will be issued.

• 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: 13541107
• MDR Text Key: 285670422
• Report Number: 9612164-2022-00635
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

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: 02/08/2022
• Initial Date FDA Received: 02/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male