MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a gunther tulip filter.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).Investigation is still in progress.

Event Description

Description of event according to journal article: surgical removal of a günther tulip filter with symptomatic caval penetration after unsuccessful percutaneous retrieval¿ by jeong kye hwang et al.A (b)(6) man was admitted to our emergency center with severe stabbing right flank pain, radiating to his right lower back the day after an unsuccessful attempt to remove a gt filter placed 22 days earlier.Retrieval of the filter did not seem too difficult.We attempted to capture the hook of the filter through a right internal jugular approach for 1 hour, but the attempts failed because the hook was incorporated into the wall of the ivc.We then attempted to retrieve the gt filter using a snared-loop technique, which resulted in the filter migrating upward with splaying of the legs.Filter retrieval was unsuccessful using the jugular vein approach because of the inability to snare the filter hook, which was incorporated into the wall of the vena cava.The patient was discharged home without any symptoms.In the er, the day after the attempted filter retrieval, an abdominal radiograph showed caudal migration with 30 degrees tilting and more splaying of the filter legs.Contrast-enhanced ct confirmed penetration of the struts into the peritoneal space, the second portion of the duodenum, and the right renal vein.Physical examination revealed right flank tenderness and muscle guarding.The laboratory studies revealed a hematocrit level of 29.2% and a white blood cell count of 7,840 cell/mm3, with 61.9% neutrophils, a platelet count of 226,000 cell/ mm3, and an international normalized ratio (inr) of 1.37.After a discussion with the patient and interventional radiologist who performed the procedure, the decision was made to remove the filter by surgery.The patient underwent transperitoneal exploration for the vena cava filter, which showed the filter struts to be penetrating the second portion of the duodenum and right renal vein without significant fluid collection.The filter was removed through a longitudinal incision of the cava wall and a transverse incision of the right renal vein.After the operation, the patient remained stable and the pain resolved.The patient remained asymptomatic for 6 months after surgery.Patient outcome: after the operation, the patient remained stable and the pain resolved.The patient remained asymptomatic for 6 months after surgery.

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a gunther tulip filter.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).Summary of investigational findings: investigation is based on attached article and image review.According to the description of event, the filter hook was incorporated into the ivc wall making the filter retrieval difficult and unsuccessful after a filter dwell time of 22 days.Manipulation during the unsuccessful filter retrieval resulted in the filter migrating upward with splaying of the legs and resulting in significant change in location and tilt of filter.The day after the retrieval attempt the patient presented with right flank pain and imaging demonstrated the filter was significantly tilted and had perforated the ivc; all 4 primary legs demonstrated grade 3 interactions involving duodenum, vertebral body, as well as the right psoas muscle.Also, displaced and fractured secondary legs project into the right renal vein with suggestion of perforation through the right renal vein.The filter was surgically removed.The conclusion of the article "symptomatic caval penetration by a gunther tulip ivc filter" is somewhat misleading, as the symptoms and penetration are likely a direct result of the retrieval attempt and potential errors made during same, and not intrinsically related to the filter.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to journal article: surgical removal of a günther tulip filter with symptomatic caval penetration after unsuccessful percutaneous retrieval¿ by jeong kye hwang et al.A (b)(6) man was admitted to our emergency center with severe stabbing right flank pain, radiating to his right lower back the day after an unsuccessful attempt to remove a gt filter placed 22 days earlier.Retrieval of the filter did not seem too difficult.We attempted to capture the hook of the filter through a right internal jugular approach for 1 hour, but the attempts failed because the hook was incorporated into the wall of the ivc.We then attempted to retrieve the gt filter using a snared-loop technique, which resulted in the filter migrating upward with splaying of the legs.Filter retrieval was unsuccessful using the jugular vein approach because of the inability to snare the filter hook, which was incorporated into the wall of the vena cava.The patient was discharged home without any symptoms.In the er, the day after the attempted filter retrieval, an abdominal radiograph showed caudal migration with 30 degrees tilting and more splaying of the filter legs.Contrast-enhanced ct confirmed penetration of the struts into the peritoneal space, the second portion of the duodenum, and the right renal vein.Physical examination revealed right flank tenderness and muscle guarding.The laboratory studies revealed a hematocrit level of 29.2% and a white blood cell count of 7,840 cell/mm3, with 61.9% neutrophils, a platelet count of 226,000 cell/ mm3, and an international normalized ratio (inr) of 1.37.After a discussion with the patient and interventional radiologist who performed the procedure, the decision was made to remove the filter by surgery.The patient underwent transperitoneal exploration for the vena cava filter, which showed the filter struts to be penetrating the second portion of the duodenum and right renal vein without significant fluid collection.The filter was removed through a longitudinal incision of the cava wall and a transverse incision of the right renal vein.After the operation, the patient remained stable and the pain resolved.The patient remained asymptomatic for 6 months after surgery.Patient outcome: after the operation, the patient remained stable and the pain resolved.The patient remained asymptomatic for 6 months after surgery.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6212095
• MDR Text Key: 63475989
• Report Number: 3002808486-2016-01570
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR