RECOVERY FILTER SYSTEM
Report
- Report Number
- 2020394-2020-01954
- Event Type
- Injury
- Date Received
- March 25, 2020
- Date of Event
- April 6, 2006
- Report Date
- August 17, 2020
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K031328
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- 003
Narratives
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: SAEED, I., GARCIA, M., MCNICHOLAS, K. (2006). RIGHT VENTRICULAR MIGRATION OF A RECOVERY IVC FILTER¿S FRACTURED WIRE WITH SUBSEQUENT PERICARDIAL TAMPONADE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 29(4), 685¿686. DOI: 10.1007/S00270-005-0136-7.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY TITLED " RIGHT VENTRICULAR MIGRATION OF A RECOVERY IVC FILTER FRACTURED WIRE WITH SUBSEQUENT PERICARDIAL TAMPONADE " THAT 4 MONTHS AFTER FILTER PLACEMENT, SHORT ARM OF THE FILTER WAS MIGRATED TO THE RIGHT VENTRICLE AND PROTRUDING THROUGH IT CAUSING LACERATION, HEMOPERICARDIUM AND CARDIAC TAMPONADE. A STERNOTOMY REQUIRED FOR REPAIR OF THE LACERATION AND THEN MIGRATED ARM AND FILTER WAS REMOVED. ABOUT 4 DAYS POSTOPERATIVELY, LUNG PERFUSION STUDY FINDINGS WERE RELATED TO THE PULMONARY EMBOLISM (PE) WHICH REQUIRED AN ADDITIONAL INTERVENTION. THE PATIENT WAS DISCHARGED AFTER STABLE CONDITION.
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: SAEED, I., GARCIA, M., MCNICHOLAS, K. (2006). RIGHT VENTRICULAR MIGRATION OF A RECOVERY IVC FILTER¿S FRACTURED WIRE WITH SUBSEQUENT PERICARDIAL TAMPONADE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 29(4), 685¿686. DOI: 10.1007/S00270-005-0136-7.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY TITLED " RIGHT VENTRICULAR MIGRATION OF A RECOVERY IVC FILTER FRACTURED WIRE WITH SUBSEQUENT PERICARDIAL TAMPONADE " THAT 4 MONTHS AFTER FILTER PLACEMENT, SHORT ARM OF THE FILTER WAS MIGRATED TO THE RIGHT VENTRICLE AND PROTRUDING THROUGH IT CAUSING LACERATION, HEMOPERICARDIUM AND CARDIAC TAMPONADE. A STERNOTOMY REQUIRED FOR REPAIR OF THE LACERATION AND THEN MIGRATED ARM AND FILTER WAS REMOVED. ABOUT 4 DAYS POSTOPERATIVELY, LUNG PERFUSION STUDY FINDINGS WERE RELATED TO THE PULMONARY EMBOLISM (PE) WHICH REQUIRED AN ADDITIONAL INTERVENTION. THE PATIENT WAS DISCHARGED AFTER STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342943 | RECOVERY FILTER SYSTEM | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | INTRAVENOUS HEPARIN| INTRAVENOUS HEPARIN |