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 2020-02-03 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
[177541832]
Other relevant device(s) are: product id: sg-64, serial/lot #: (b)(4), ubd: 08-jul-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177541833]
An endurant iis stent graft system was in a patient for the endovascular treatment of a 24mm abdominal aortic aneurysm. Eight heli-fx endoanchors were also deployed during the procedure due to concern for late failure. It was reported that the patient presented with generalised abdominal pain in the post-operative period with associated diarrhoea. Ct angiogram also showed generalised thickening of the wall of the descending colon with transient ischemia. It was reported that the patient recovered with treatment the day after the index procedure. The event was assessed by the investigator to be related to the index procedure. No additional clinical sequelae were reported, and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-00517 |
| MDR Report Key | 9658943 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-02-13 |
| Date Added to Maude | 2020-02-03 |
| 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 | 2020-02-03 |
| Model Number | SA-85 |
| Catalog Number | SA-85 |
| Lot Number | 0009590597 |
| 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 | 2020-02-03 |