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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Blood Loss (2597); No Code Available (3191)
Event Type  Death  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. Journal article: hing-chung, lee, et. Al. (1994) lethal pulmonary embolism in a patient with primary antiphospholipid syndrome and a vena caval filter chest, v 105: issue 1; 312-13. Patient code: adverse effects, blood loss/hemorrhage and death are addressed in the ifu. Device code: potential adverse effects are addressed in the ifu. Event is still under investigation.
 
Event Description
The journal article alleged that in november, 1990, a (b)(6) female was admitted to (b)(6) hospital at the (b)(6)medical center with recurrent pulmonary emboli that were confirmed by pulmonary angiography. A birds nest filter was placed in the inferior vena cava to prevent further pulmonary emboli. Her clinical condition temporarily stabilized and the platelet count normalized after treatment with low-dose heparin, 5,000 u subcutaneously twice daily and aspirin, 100 mg/d and she was discharged from the hospital on this regimen. She was readmitted to the hospital 7 months later with acute cholecystilis and underwent cholecystectomy that evening. Following cholecystectomy, she developed progressive thrombocytopenia and required 21 u of packed red blood cells for blood loss. Low-dose heparin treatment was restarted immediately postoperatively. Aspirin treatment was withheld for 2 days, then restarted again on the third hospital day. On the fifth postoperative day, she had been walking around the nurse's station when she developed acute shortness of breath, diaphoresis, tachycardia, and peripheral cyanosis. An emergency pulmonary angiogram showed a large segmental perfusion defects in the lingual and posterior aspects of the upper lobe of the left lung and large occlusive thrombus in the descending branch of the right pulmonary artery. Catheter-directed thombolsis was attempted with 250,000 iu of urokinase, diluted 30,000/10 ml of sterile water, injected over a period of 10 min. After a 10-min interval, an additional 500,000 iu were administered in a similar manner. Repeated contrast imaging showed only minimal improvement in perfusion of the lung. Repeated blood gas measurements showed no change in oxygenation. She became hypotensive and bradycardiac during the procedure and died en route to surgery for emergency embolectomy. At autopsy, both recent and organized thromboemboli within recanalizing pulmonary vasculature were noted. One possible source of thrombi included the inferior vena caval birds nest filter, which showed both recent and organized thombus formation extending proximally from the filter.
 
Manufacturer Narrative
Journal article: hing-chung, lee, et. Al. (1994) lethal pulmonary embolism in a patient with primary antiphospholipid syndrome and a vena caval filter. Chest, v 105: issue 1; 312-13. (b)(4). Investigation - evaluation. A review of complaint history, instructions for use (ifu) and quality control was conducted during the investigation. The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: device description and intended use as well as contraindications, warnings, precautions and instructions for device placement and use. The ifu includes the following warning: ¿no technique will completely eliminate the possibility of recurrent pte. (with the bird¿s nest vena cava filter, the observed incidence of recurrent pte clinically acceptable. ¿ the ifu also includes a list of potential adverse events. Pulmonary embolism and death are listed among the potential adverse events. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. Taking into consideration the event description in the article, the patient's condition, paps, indicates a hypercoagulable state, it is reasonable to suggest that this condition is the root cause of the event with the surgery and post-surgical complications coupled with the placed bird's nest filter contributing to the patient outcome. The optimal dose and choice of anticoagulant is not known according to the article. The article concludes that "in summary, prophylactic treatment with low-dose heparin and aspiring in the patient with paps with a previously placed vena cava filter failed to prevent post-operative thrombotic complications. " the authors conclude that they ". Believe that consideration should be given to more aggressive anticoagulation therapy to avoid postoperative thromboembolism in these patients, particularly in those patients with a previously placed vena caval filter. " the appropriate internal personnel have been notified and we will continue to monitor for similar complaints. Per the quality engineering risk assessment (qera) no further action is required.
 
Event Description
Lee, hing-chung, et. At chest (1994); 105: 312-313. Lethal pulmonary embolism in patient with vena caval filter. The journal article alleged that in (b)(6) 1990, a (b)(6) female was admitted to (b)(6) medical center with recurrent pulmonary emboli that were confirmed by pulmonary angiography. A birds nest filter was placed in the inferior vena cava to prevent further pulmonary emboli. Her clinical condition temporarily stabilized and the platelet count normalized after treatment with low-dose heparin, 5,000 u subcutaneously twice daily and aspirin, 100 mg/d and she was discharged from the hospital on this regimen. She was readmitted to the hospital 7 months later with acute cholecystitis and underwent cholecystectomy that evening. Following cholecystectomy, she developed progressive thrombocytopenia and required 21 u of packed red blood cells for blood loss. Low-dose heparin treatment was restarted immediately postoperatively. Aspirin treatment was withheld for 2 days, then restarted again on the third hospital day. On the fifth postoperative day, she had been walking around the nurse's station when she developed acute shortness of breath, diaphoresis, tachycardia, and peripheral cyanosis. An emergency pulmonary angiogram showed a large segmental perfusion defects in the lingual and posterior aspects of the upper lobe of the left lung and large occlusive thrombus in the descending branch of the right pulmonary artery. Catheter-directed thrombolysis was attempted with 250,000 iu of urokinase, diluted 30,000/10 ml of sterile water, injected over a period of 10 min. After a 10-min interval, an additional 500,000 iu were administered in a similar manner. Repeated contrast imaging showed only minimal improvement in perfusion of the lung. Repeated blood gas measurements showed no change in oxygenation. She became hypotensive and bradycardiac during the procedure and died en route to surgery for emergency embolectomy. At autopsy, both recent and organized thromboemboli within recanalizing pulmonary vasculature were noted. One possible source of thrombi included the inferior vena caval birds nest filter, which showed both recent and organized thombus formation extending proximally from the filter.
 
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Brand NameGIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key5720205
MDR Text Key47226880
Report Number1820334-2016-00424
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P850049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Nursing Home
Date Manufacturer Received05/16/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2016 Patient Sequence Number: 1
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