MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-05-31 for VALIANT CAPTIVIA - FF VAMF2828C150TE manufactured by Medtronic Ireland.
[146955427]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146955428]
A valiant stent graft system was implanted in a patient for the endovascular treatment of a thoracic ulcer. It was reported during the index procedure, during the deployment of the stent graft, the proximal bare stents were unable to be released. The release wheel of the delivery system became stuck and the physician was unable to rotate. The outer casing of the delivery system was forcibly disassembled and the proximal bare stents opened and the device implanted successfully. Per the physician, the cause of the event was product related. No clinical sequelae were reported and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[170803925]
Photo evaluation: the tip capture release handle had been removed from the returned delivery system. A break was visible between the clamping ring and the back end lock. Two kinks were visible on the exposed peek tubing. The graft cover was kinked between 12. 3 and 15. 1cm distal to the strain relief. The handle was disassembled to inspect the silicone seal. There was no resistance moving the silicone seal along the peek tubing. On removal residue was visible inside the seal. A residue ring was visible on the peek tubing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187374854]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187375617]
Film analysis summary: the exact cause of the reported deployment difficulties, inability to release the proximal bare stents, could not be determined from the single returned pre-implant image. Complete pre-implant ct? S were not provided; therefore, a comprehensive assessment of the patient? S anatomy could not be performed. Films during implant were also not available for return and the reported event could not be assessed. Analysis of the returned film did not reveal any anatomical characteristics that could explain the reported event. A device issue cannot be ruled out as a potential cause. The delivery system has been returned for investigation and is pending analysis, and the results will be summarized in a separate report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-02126 |
| MDR Report Key | 8658002 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-05-31 |
| Date of Report | 2019-08-12 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-07-17 |
| Device Manufacturer Date | 2018-12-17 |
| Date Added to Maude | 2019-05-31 |
| 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 | VALIANT CAPTIVIA - FF |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-05-22 |
| Model Number | VAMF2828C150TE |
| Catalog Number | VAMF2828C150TE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-31 |