MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for UNKNOWN manufactured by William Cook Europe.
[188824756]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188824757]
Description of event according to initial reporter: it is alleged that patient received a cook celect filter on (b)(6) 2013. The patient reportedly experienced filter fracture, organ/ vena cava perforation by the filter, and filter tilt. Ct (computed tomography): "inferior vena cava filter at the level of the renal veins with multiple prongs extending to the caval wall and into the surrounding structures, including a prong piercing the anterior inferior parenchyma of the right kidney with an area decreased surrounding enhancement. " "there is an inferior vena cava filter at the level of the renal veins. Two of the posterior prongs extend through the cava wall into the ipsilateral psoas muscle. Two of the right-sided prongs extend and terminate in the right renal vein. One of the right-sided prong extends through the caval wall and into the parenchyma of the anterior inferior kidney. The surrounding parenchyma demonstrates decreased enhancement around this prong. In addition, there is an anterior prong which extends through the anterior portion of the caval wall. There is a left-sided prong which extends to the caval wall and into the prevertebral soft tissues. " successful retrieval report: "scout images demonstrated a tilted ivc filter with 2 struts with caval penetration. " "post filter removal venogram did not demonstrate extravasation. " "scout images of the chest and abdomen did not demonstrate evidence for any retained filter fragments. " "tilted infrarenal celect ivc filter with leg perforating into the right renal parenchyma. One upper stabilizing strut is fractured. Successful removal of indwelling ivc filter in its entirety using endobronchial forceps. The fragment was removed as well separately using forceps. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005580113-2020-00310 |
| MDR Report Key | 9889351 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Facility Aware | 2020-03-11 |
| Report Date | 2020-03-27 |
| Date Reported to FDA | 2020-03-27 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Product Code | DTK |
| Date Received | 2020-03-27 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-27 |