MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-26 for G2 FILTER UNKNOWN G2 manufactured by Bard Peripheral Vascular, Inc..
[185227311]
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Journal article citation: kim, h. S. , young, m. J. , narayan, a. K. , hong, k. , liddell, r. P. , & streiff, m. B. (2008). A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. Journal of vascular and interventional radiology, 19(3), 393? 399. Doi: 10. 1016/j. Jvir. 2007. 09. 019.
Patient Sequence No: 1, Text Type: N, H10
[185227312]
It was reported in an article in the journal of vascular and interventional radiology (jvir) titled "a comparison of clinical outcomes with retrievable and permanent inferior vena cava filters " that after filter placement, new symptomatic pulmonary embolism (pe) was identified in 5 patients. The status of the patients was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-02088 |
| MDR Report Key | 9887111 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2007-09-17 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G2 FILTER |
| Generic Name | VENA CAVA FILTER |
| Product Code | DTK |
| Date Received | 2020-03-26 |
| Catalog Number | UNKNOWN G2 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-26 |