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

Model Number N/A

Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)

Patient Problems Embolism (1829); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Journal article: buckley, orla md, et.Al.(2010), embolism after inferior vena cava filter mesh fragmentation, 10.1016/j.Jvir.2010.07.010.(b)(4).The event is currently under investigation.

Event Description

A journal article alleged that, a (b)(6) woman presented 15 months ago with a chief complaint of progressive shortness of breath and palpitations for several months.She had a history of chronic thromboembolic pulmonary hypertension first diagnosed 10 years previously by pulmonary angiography.She was anti- coagulated with warfarin, but her symptoms of increasing dyspnea recurred 8 years ago.Repeat pulmonary angiography at this time showed elevated pulmonary arterial pressures (mean 40 mm hg).Before undergoing pulmonary thromboendarterectomy, a bird¿s nest vena caval filter was inserted in the infrarenal inferior vena cava, and she was well maintained on warfarin with a goal of an international normalized ratio of 2.5¿3.5.On admission 15 months ago, the patient¿s blood pressure was 124/90 mm hg, and her heart rate was 90 beats/ min.The cardiopulmonary clinical examination was normal.To evaluate cardiac structure and function (particularly of the right heart), 1.5-tesla cardiac magnetic resonance (mr) imaging was performed and showed extensive susceptibility artifact in the right ventricle, strongly suggesting a metallic foreign body.The patient was removed from the magnetic field without complication.Subsequent multidetector computed tomography (ct) of the chest and abdomen identified the fractured infrarenal inferior vena cava filter and multiple metallic fragments at the tricuspid valve, by the right ventricular apex, and the segmental and subsegmental right lower lobe pulmonary arteries.No evidence of pulmonary embolism or vena cava thrombus was identified on contrast-enhanced ct.The fragments were retrieved using fluoroscopic guidance.The fragment in the tricuspid valve was pushed with a pigtail catheter into the left pulmonary artery to avoid snaring the tricuspid valve apparatus.A 7-f ansel sheath from the internal jugular approach was used to snare (5-mm amplatz goose neck snare) this fragment.Six fragments in the right lower lobe pulmonary artery were sequentially snared and retrieved without complication.Two fragments in the apical right ventricle could not be snared because of provocation of ventricular tachycardia.Some filter mesh fragments in the right main pulmonary artery were embedded and could not be retrieved.The retrieved fragments were found to be fragments of the filter mesh and not filter struts.The patient reported clinical improvement after fragment retrieval, now almost 15 months after the procedure, with interval resolution of her palpitations and tachycardia.The decision for retrieval was based on the presumption that the fragments in the pulmonary artery and right ventricle were contributing to the patient¿s dyspnea and tachycardia, combined with concern about the long term risk of vascular or myocardial perforation.Future management of this patient is controversial.Removal from the vena cava would require laparotomy.There is also concern related to the remnants of the filter mesh that remain in the pulmonary artery and the right ventricular apex.The current approach is watchful waiting¿a conservative strategy¿and is based primarily on abatement of the patient¿s symptoms after retrieval of filter fragments.A close follow-up is planned.

Manufacturer Narrative

Journal article: buckley, orla md, et.Al.(2010) embolism after inferior vena cava filter mesh fragmentation 10.1016/j.Jvir.2010.07.010.(b)(4).Correction to date received by manufacturer initial was filed within the 30 day time frame regardless of corrected date.Clinical opinion: it was reported that "future management of this patient is controversial.Removal from the vena cava would require laparotomy.There is also concern related to the remnants of the filter mesh that remain in the pulmonary artery and the right ventricular apex.Our current approach is watchful waitinga conservative strategyand is based primarily on abatement of the patients symptoms after retrieval of filter fragments.We plan close follow-up".Based on the available information it is not very clear if the leading cause to this event can be associated with a pre-existing patient condition, the medical procedure or a malfunction of the device.Investigation - evaluation a review of the complaint history, drawings, instructions for use (ifu), manufacturing instructions, specifications and quality control was conducted during the investigation.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.The lot number is not known, accordingly a review of the device manufacturing records could not be conducted.Design testing was conducted to confirm adequate fatigue strength in the filter struts and the product is inspected for 100% verification of length, position, spacing and bevel type of the barbs.The product is shipped with an ifu which lists the anatomical requirements, warnings and precautions, and correct deployment procedure.The exact ifu is dependent on product size and placement approach.Without the exact device product code, we cannot determine the exact ifu.However, in each ifu, perforation of vena cava wall is listed as a potential adverse event.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.(b)(4).

Event Description

A journal article alleged that, a (b)(6) year-old woman presented 15 months ago with a chief complaint of progressive shortness of breath and palpitations for several months.She had a history of chronic thromboembolic pulmonary hypertension first diagnosed 10 years previously by pulmonary angiography.She was anti-coagulated with warfarin, but her symptoms of increasing dyspnea recurred 8 years ago.Repeat pulmonary angiography at this time showed elevated pulmonary arterial pressures (mean 40 mm hg).Before undergoing pulmonary thromboendarterectomy, a birds nest vena caval filter was inserted in the infrarenal inferior vena cava, and she was well maintained on warfarin with a goal of an international normalized ratio of 2.53.5.On admission 15 months ago, the patients blood pressure was 124/90 mm hg, and her heart rate was 90 beats/ min.The cardiopulmonary clinical examination was normal.To evaluate cardiac structure and function (particularly of the right heart), 1.5-tesla cardiac magnetic resonance (mr) imaging was performed and showed extensive susceptibility artifact in the right ventricle, strongly suggesting a metallic foreign body.The patient was removed from the magnetic field without complication.Subsequent multidetector computed tomography (ct) of the chest and abdomen identified the fractured infrarenal inferior vena cava filter and multiple metallic fragments at the tricuspid valve, by the right ventricular apex, and the segmental and subsegmental right lower lobe pulmonary arteries.No evidence of pulmonary embolism or vena cava thrombus was identified on contrast-enhanced ct.The fragments were retrieved using fluoroscopic guidance.The fragment in the tricuspid valve was pushed with a pigtail catheter into the left pulmonary artery to avoid snaring the tricuspid valve apparatus.A 7-f ansel sheath from the internal jugular approach was used to snare (5-mm amplatz goose neck snare) this fragment.Six fragments in the right lower lobe pulmonary artery were sequentially snared and retrieved without complication.Two fragments in the apical right ventricle could not be snared because of provocation of ventricular tachycardia.Some filter mesh fragments in the right main pulmonary artery were embedded and could not be retrieved.The retrieved fragments were found to be fragments of the filter mesh and not filter struts.The patient reported clinical improvement after fragment retrieval, now almost 15 months after the procedure, with interval resolution of her palpitations and tachycardia.The decision for retrieval was based on the presumption that the fragments in the pulmonary artery and right ventricle were contributing to the patients dyspnea and tachycardia, combined with concern about the long term risk of vascular or myocardial perforation.Future management of this patient is controversial.Removal from the vena cava would require laparotomy.There is also concern related to the remnants of the filter mesh that remain in the pulmonary artery and the right ventricular apex.The current approach is watchful waitinga conservative strategyand is based primarily on abatement of the patients symptoms after retrieval of filter fragments.A close follow-up is planned.

• Brand Name: GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
• Type of Device: DTK 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 Key: 5723213
• MDR Text Key: 47334579
• Report Number: 1820334-2016-00523
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P850049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• 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 Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2016
• 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): Required Intervention
• Patient Age: 65 YR