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 2020-02-07 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[178118164]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178118165]
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 55mm abdominal aortic aneurysm. Endoanchors were also implanted during the procedure due to concern for late failure. The proximal neck angulation was noted to be 35 degrees. There was 30% diffuse thrombus and 20% diffuse calcium noted at the seal zone. It was reported that a type ia endoleak was observed during the procedure and an aortic cuff and an additional three endoanchors were implanted (from the aortic cuff to aortic neck) as treatment. There was no endoleak observed at the end of the procedure. It was reported that follow up ct carried out approximately two and a half weeks post the index procedure showed a new type ia endoleak. The type ia endoleak was assessed by the investigator to be probably related to the index procedure and possible related to a device (it was noted it is uncertain which one). The event is unresolved, and the patient is continuing without treatment. No additional clinical sequelae were reported, and the patient is being monitored. Medical history: past tobacco use, hypertension, hyperlipemia, diabetes, angina, carotid disease.
Patient Sequence No: 1, Text Type: D, B5
[188590162]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00616 |
| MDR Report Key | 9680950 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-05-15 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-02-13 |
| Date Added to Maude | 2020-02-07 |
| 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 Phone | 091708096 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO ANCHOR SYSTEM - HELI-FX AAA |
| Generic Name | ENDOVASCULAR SUTURING SYSTEM |
| Product Code | OTD |
| Date Received | 2020-02-07 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009590597 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |