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

Device Problem Entrapment of Device (1212)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Erosion (1750); Tissue Damage (2104)

Event Date 07/17/2015

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.The ifu includes "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention", "vena cava stenosis or occlusion", and "vasospasm or decreased/impaired blood flow" as potential complications.

Event Description

According to the notice received by way of a civil action complaint filed on july 7, 2017, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2015.The patient had a scheduled removal approximately 4 months later, on or about (b)(6) 2015 at community medical center in (b)(6).The physician (unidentified) was unable to retrieve the filter.The patient underwent a second retrieval attempt later that day, by dr.(b)(6).Dr.(b)(6) allegedly found at least one leg of the filter in the subcutaneous tissue.The device itself was found to have eroded and thinned the vein wall and was noted to be protruding through the vein.Dr.(b)(6) was able to extract the filter and repair the posterior wall.However, the plaintiff went on to suffer post-surgical complications, including pulmonary embolism related to the need for surgical intervention to retrieve the filter and subsequent anti-coagulation therapy due to damage to common femoral vein.The patient alleges to have suffered injuries as described above.Argon¿s attorneys are attempting to gather additional 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: 6778229
• MDR Text Key: 82187463
• Report Number: 1625425-2017-00109
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention