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 2019-11-28 for ENDO ANCHOR SYSTEM - HELI-FX TAA HA-18-114 manufactured by Medtronic Ireland.
[168452722]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[168452723]
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size. Approximately 8 years post index procedure a revision procedure was performed prophylactically due to neck dilation with heli-fx endoanchors implanted. It was reported that approximately 13 months post the revision procedure, a type 1a endoleak was observed. An additional endovascular fevar procedure was performed as treatment and the event is resolved. As per the physician, the event was related to the aortic aneurysm treated by the endoanchors. No additional clinical sequelae were reported and the patient recovered.
Patient Sequence No: 1, Text Type: D, B5
[188198867]
Additional information received; a ct with contrast was performed and a increasing volume type ia endoleak was observed. The aneurysm diameter measured 44mm. This has been assessed by the site as related to the aneurysm treated by the endoanchors. A re-intervention endovascular procedure was performed where a aortic cuff was implanted as a proximal extension and this event resolved 3 months later. This event has been assessed by the sponsor as not related to the study procedure and probably related to the study device (endoanchor). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188198940]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188198941]
It was noted that the anemia/decrease in hemoglobin was due to a hematoma in the left armpit which was first noted two weeks post the re-intervention procedure. The patient had lack of energy and swelling of the left armpit. The event was resolved and the patient recovered after treatment. It was confirmed that the 'bouble' aneurysm refers to an aneurysm with a relative decrease in diameter in the middle of the aneurysm which caused two 'bubbles'.
Patient Sequence No: 1, Text Type: D, B5
[188199172]
Additional information received: it was reported that approximately 2 weeks post the additional fevar procedure, a decrease of hemoglobin was observed. The patient was treated with medication and a blood transfusion. The event has not been assessed by the investigator. The type ia endoleak was reported to be known type ia endoleak cranial bouble aneurysm with a light increase in diameter, max 51 mm (from 48 mm in 2017). The endoleak has somewhat increased in volume and is located slightly more caudal to the endoanchor but not to the caudal bouble. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188199306]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-04940 |
| MDR Report Key | 9390176 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-28 |
| Date of Report | 2019-11-29 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2019-11-22 |
| Device Manufacturer Date | 2017-03-02 |
| Date Added to Maude | 2019-11-28 |
| 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 TAA |
| Generic Name | ENDOVASCULAR SUTURING SYSTEM |
| Product Code | OTD |
| Date Received | 2019-11-28 |
| Model Number | HA-18-114 |
| Catalog Number | HA-18-114 |
| Device Expiration Date | 2019-02-28 |
| 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 | 2019-11-28 |