MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER

Catalog Number 352506070

Device Problems Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528)

Patient Problems Abdominal Pain (1685); Embolism (1829); Respiratory Distress (2045); Thrombosis (2100); Injury (2348)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.¿device breakage or failure or inability to retrieve implanted device as described in ifu, possibly requiring another intervention or treatment modality to complete procedure¿, "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "thromboembolic events, including dvt, acute or recurrent pulmonary embolism or air embolism, possibly causing end organ infarction/damage/failure", and "injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention" are potential complications cited in the ifu associated with this product.In the optional procedure for filter retrieval section of the ifu, it states: ¿if the filter is retrieved, it should be done within 175 days following implant.¿ this device can remain permanently implanted.

Event Description

According to notification received on january 9, 2017, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2010 by dr.(b)(6) at (b)(6) hospital in (b)(6).It is not known if there have been any defects or issues with the filter and/or if the filter was retrieved or attempted to be retrieved.Argon¿s attorneys are attempting to gather information.Additional information received on april 6, 2017: according to the notice received by way of a civil action complaint filed on april 3, 2017, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2010 by dr.(b)(6) at (b)(6) hospital in (b)(6).According to the patient, approximately 2 months later, on or about sometime in (b)(6) 2010, she suffered from respiratory distress due to a pulmonary embolism that resulted in hospitalization and was placed on anticoagulant medications.Approximately 5 years post implant, on or about (b)(6) 2015, the patient reported to her primary care doctor, dr.(b)(6), with complaints of abdominal pain, per the patient¿s attorney, the patient underwent a ct scan on or about (b)(6) 2015 that showed recurrent bilateral lower extremity dvt with chronic phlegmasia with negative thrombophilia workup, status-post thrombolysis on life-long anticoagulants.The patient had a scheduled removal approximately 5 years post implant, on or about (b)(6) 2015 with dr.(b)(6) at (b)(6) hospital in (b)(6).Despite ¿numerous efforts to snare the filter¿ it could not be removed due to embedment.It was also noted the filter had fractured which some of the fractured pieces were retrieved at this time.The patient had a second scheduled removal approximately 4 months later, on or about (b)(6) 2015 by dr.(b)(6) at (b)(6) hospital, who was unable to retrieve the filter due to embedment.The patient had a third scheduled removal approximately 2 months later, on or about (b)(6) 2015 with dr.(b)(6), who performed ¿an open exploration of the ivc via abdominal incision, direct repair of the ivc in two separate locations and removal of the remaining portions of the filter.¿ the patient alleges she had abdominal pain from the time of the implant until the ultimate removal.She is also claiming damages as result of the multiple surgeries and hospitalizations, as well as damage to her vena cava and surrounding vessels and organs.Argon¿s attorneys are attempting to gather information.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6492478
• MDR Text Key: 72783849
• Report Number: 1625425-2017-00009
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070
• Device Lot Number: S31002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2010
• 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): Hospitalization; Required Intervention