Gianturco-Roehm Bird's Nest G06451Recalls & reported problems
Cook Incorporated · Gianturco-Roehm Bird's Nest Vena Cava Filter · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002064515), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Kinked1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2017Kinked; Material Separation; Kinked; Material Separation
IT WAS REPORTED THAT DURING A (B)(6) BIRD'S NEST FEMORAL VENA CAVA FILTER PLACEMENT PROCEDURE, WHEN THE FILTER WAS ADVANCED THROUGH THE SHEATH, THE SHEATH KINKED AND TORE. A SECOND ONE WAS OPENED FROM A DIFFERENT LOT NUMBER, IT WAS SEVERELY BENT AND THE FACILITY WAS UNABLE TO ADVANCE THE FILTER THROUGH IT. THE FIRST TWO FILTERS HAD FEMORAL ACCESS. THE FACILITY OPENED UP A 3RD DEVICE AND UTILIZED JUGULAR ACCESS. THEY WERE ABLE TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PRODUCT CAUSED OR CONTRIBUTED TO THE NEED FOR AN ADDITIONAL ACCESS SITE AS THEY SWITCHED FROM FEMORAL TO JUGULAR ACCESS. NO ADDITIONAL ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6663653 ↗
Other FILTER, INTRAVASCULAR, CARDIOVASCULAR devices
- Denali® Vena Cava Filter DL900FBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 reports
- DENALI® Vena Cava Filter DL900JBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR15 deaths492 reports
- Option Elite Retrievable Vena Cava Filter System 352506070EArgon Medical Devices, Inc. · Filter, Intravascular, Cardiovascular2 recalls3 deaths342 reports
- Gunther Tulip G33016Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths348 reports
- Gunther Tulip G33017Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths286 reports
- Cook Celect G34309William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death230 reports
- Gunther Tulip G52916William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths189 reports
- Cook Celect G34502William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths165 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.