MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for ENDURANT STENT GRAFT manufactured by Medtronic Ireland.
[185225330]
Medtronic received the following information from the journal article entitled:?? Morbidity and mortality following endovascular repair of abdominal aortic aneurysms in the elderly?? Daniel silverberg, ahmad abu rmeileh, daniel raskin, uri rimon and moshe halak israel medical association journal 2020 vol 22, issue 1. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185225331]
Endurant stent grafts and non-mdt stent grafts were implanted in patients for endovascular aortic repair. The following events were reported: serious injury: pneumonia, aspiration and copd exacerbation ischemic colitis aneurysm rupture sepsis distal embolisation leading to rhabdomyolysis, buttock necrosis and renal failure cardiac arrest gastrointestinal complications renal/urinary track complications respiratory complications bleeding limb occlusion cerebrovascular accident re-intervention death-patient deaths were also reported, however there is no causal link that a medtronic device may have caused or contributed to the deaths.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01377 |
| MDR Report Key | 9888541 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALISON SWEENEY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Manufacturer Phone | 091708096 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDURANT STENT GRAFT |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |