DENALI FILTER
Report
- Report Number
- 2020394-2019-05746
- Event Type
- Injury
- Date Received
- December 20, 2019
- Report Date
- January 6, 2020
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- UDI-DI
- 00801741040818
- PMA / PMN Number
- K130366
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
H10: THE SUPPLEMENTAL IS BEING SUBMITTED FOR CORRECT G4 DATE(B)(6)2019 H10: G4 H11:G4 JOURNAL ARTICLE CITATION: LEE, S. Y., DO, Y. W., LEE, H.-J., & LEE, D. H. (2018). IATROGENIC FRACTURE OF FILTER ARM DURING REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTER USING ENDOSCOPIC FORCEPS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 29(9), 1338¿1340. DOI: 10.1016/J.JVIR.2018.02.026 H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. - ATTACHMENT: [2018 - LEE, S.PDF]
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. (DEVICE: 1528 DIFFICULT TO REMOVE, TRENDING DEVICE CODES: 2616A TILT, 2907M FILTER LIMB(S), 4001B PERFORATION). JOURNAL ARTICLE CITATION: LEE, S. Y., DO, Y. W., LEE, H.-J., & LEE, D. H. (2018). IATROGENIC FRACTURE OF FILTER ARM DURING REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTER USING ENDOSCOPIC FORCEPS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 29(9), 1338¿1340. DOI: 10.1016/J.JVIR.2018.02.026 ATTACHMENT: [2018 - LEE, S.PDF].
IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY TITLED " IATROGENIC FRACTURE OF FILTER ARM DURING REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTER USING ENDOSCOPIC FORCEPS " THAT ONE MONTH AFTER THE INSERTION OF THE FILTER INTO THE INFRARENAL INFERIOR VENA CAVA (IVC), COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A SEVERELY ANGULATED IVC FILTER. THEREFORE, THE FILTER WAS REPOSITIONED WITH ENDOSCOPIC FORCEPS, HOWEVER, DURING THE PROCEDURE ONE OF THE FILTER ARM FRACTURED AND MIGRATED TO THE RIGHT PULMONARY ARTERY. FOUR DAYS AFTER, CT REVEALED THAT THE FRACTURED ARM FURTHER MIGRATED TO THE LEFT PULMONARY ARTERY, WHICH REQUIRED WEDGE RESECTION OF THE LEFT UPPER LOBE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITHOUT ANY SEQUELAE.
IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY TITLED " IATROGENIC FRACTURE OF FILTER ARM DURING REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTER USING ENDOSCOPIC FORCEPS " THAT ONE MONTH AFTER THE INSERTION OF THE FILTER INTO THE INFRARENAL INFERIOR VENA CAVA (IVC), COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A SEVERELY ANGULATED IVC FILTER. THEREFORE, THE FILTER WAS REPOSITIONED WITH ENDOSCOPIC FORCEPS, HOWEVER, DURING THE PROCEDURE ONE OF THE FILTER ARM FRACTURED AND MIGRATED TO THE RIGHT PULMONARY ARTERY. FOUR DAYS AFTER, CT REVEALED THAT THE FRACTURED ARM FURTHER MIGRATED TO THE LEFT PULMONARY ARTERY, WHICH REQUIRED WEDGE RESECTION OF THE LEFT UPPER LOBE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITHOUT ANY SEQUELAE.
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. (B)(4). JOURNAL ARTICLE CITATION: LEE, S. Y., DO, Y. W., LEE, H.-J., & LEE, D. H. (2018). IATROGENIC FRACTURE OF FILTER ARM DURING REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTER USING ENDOSCOPIC FORCEPS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 29(9), 1338¿1340. DOI: 10.1016/J.JVIR.2018.02.026.
IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY TITLED " IATROGENIC FRACTURE OF FILTER ARM DURING REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTER USING ENDOSCOPIC FORCEPS " THAT ONE MONTH AFTER THE INSERTION OF THE FILTER INTO THE INFRARENAL INFERIOR VENA CAVA (IVC), COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A SEVERELY ANGULATED IVC FILTER. THEREFORE, THE FILTER WAS REPOSITIONED WITH ENDOSCOPIC FORCEPS, HOWEVER, DURING THE PROCEDURE ONE OF THE FILTER ARM FRACTURED AND MIGRATED TO THE RIGHT PULMONARY ARTERY. FOUR DAYS AFTER, CT REVEALED THAT THE FRACTURED ARM FURTHER MIGRATED TO THE LEFT PULMONARY ARTERY, WHICH REQUIRED WEDGE RESECTION OF THE LEFT UPPER LOBE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITHOUT ANY SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1295538 | DENALI FILTER | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | UNKNOWN | 00801741040818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |