MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-30 for 466FXXXX manufactured by Cordis Corporation.
[188522548]
The catalog number is unknown, if received it will be provided. Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter. The indication for the filter placement was not reported. At some point after the filter implantation, the patient became aware that the filter had migrated and was associated with perforation. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated. The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart. Without images or procedural films for review, the reported filter migration and perforation events could not be confirmed and the exact cause could not be determined. Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such. Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement,? Sail? Effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the ivc including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. Perforation from removable filters is relatively common, and directly related to how long the filter has been in place. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. Clinical factors that may have influenced the event include the patient? S pre-existing co-morbidities, pharmacological issues and lesion characteristics. Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[188522549]
As reported by the legal brief, the patient underwent placement of a optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages including, but not limited to: migration and perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2020-03969 |
| MDR Report Key | 9896787 |
| Report Source | OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARLA CASTRO |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 466FXXXX |
| Generic Name | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Product Code | DTK |
| Date Received | 2020-03-30 |
| Model Number | 466FXXXX |
| Catalog Number | 466FXXXX |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NW 60TH AVE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-30 |