MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[184485177]
Product analysis summary: the presence of the reported endoleaks can be confirmed from the ct provided. Pre-implant ct? S showing the patient anatomy were not provided for assessment. A type ia endoleak is visible on the 2020 follow up ct images and contrast is visible in the distal aneurysmal sac also. It is likely that disease progression with increased angulation of the aorta and dilatation of the proximal aortic neck, is a factor in the observed endoleak events. It is unclear if the calcification noted in the proximal aortic neck region has impacted on the proximal seal of the endurant cuff or the effectiveness of the heli-fx endoanchors implanted to try resolve the type ia endoleak. The high neck angulation and short proximal seal zone may have also been a factor. It is possible that implantation of the endurant limbs in an aneurysmal right iliac artery may have lead to loss of seal in this area due to disease progression. Analysis of the returned films did not reveal any device issues that could explain the reported event. Films during or post-intervention were not provided. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184485178]
An endurant bifurcate and an endurant limb were implanted in the endovascular treatment of a 80mm abdominal aortic aneurysm. It was noted that when the patient returned for follow-up, a ct performed seven years and seven months later, it showed a type ia endoleak was present in the bifurcate. A endoleak type ib was present in the right common iliac artery in the endurant limb also. Sixteen days post the ct, this patient was brought to or. A 25x25x49 endurant cuff was deployed to the level of the lowest (right) renal artery and subsequently 6 endoanchors were deployed in the lateral and posterior right and left oblique regions of the proximal cuff in an unsuccessful attempt to seal the type 1a endoleak. As per the physician it was determined that a posterior chunk of calcium at the level of the proximal seal zone in the aorta was creating a gutter that prevented the cuff from achieving a complete proximal seal. To address the type ib endoleak a 16x13x156 tapered endurant limb was used to extend seal into the right external iliac artery. After this was implanted, the physician implanted an additional 16x13x124 limb to extend the distal seal an additional 1. 5-2cm. The completion angiogram showed that the type ia endoleak was persisting but the type ib endoleak had resolved. It was reported during the intervention to treat the type ia endoleak using the endoanchors, the first heli-fx guide was inadvertently bent acutely and got a kink in it while being passed from the back table and through the introducer sheath. Due to the tortuous anatomy, it was decided to open the second guide to avoid any challenges with wire access or anchor deployment. The cause of the kink was reportedly due to handling issues. As per the physician the cause of the type i endoleaks was disease progression. No additional clinical sequelae were provided and the patient will be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01284 |
| MDR Report Key | 9864497 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-02-21 |
| Date Added to Maude | 2020-03-23 |
| 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 | ENDO ANCHOR SYSTEM - HELI-FX AAA |
| Generic Name | ENDOVASCULAR SUTURING SYSTEM |
| Product Code | OTD |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-02-10 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009606197 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-23 |