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

Catalog Number UNKNOWN

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot #: unknown as information was not provided.Catalog #: unknown but referred to as a ivc filter.Expiration date: unknown as lot # is unknown.Since catalog# is unknown the 510(k) could be either k061815 or k073374.Mfr date is unknown as lot # is unknown.Investigation is still in progress.

Event Description

Description of event according to complainant: the physician was removing an ivc filter that had been implanted in a patient for approximately 8 years by another physician and another unknown facility.It was noted that a main strut had broken off and is embedded in the ivc vena cava.The physician decided not to attempt removal and will be keeping an eye on the patient.Additional information, per the dm: "i spoke with dr again and he said the leg fractured during removal.The pt was having pain which is why he chose to remove the filter." patient outcome: the fractured leg remains in the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a ivc filter.Since catalog# is unknown the 510(k) could be either k061815 or k073374.Summary of investigational findings: no imaging was provided and only very limited information.Therefore, it is not possible to comment on the filter leg, which was removed approx.8 years after filter implant, because patient was having pain.Also, it is not possible to comment on the filter fracture during removal.In this case patient was symptomatic reported as pain leading to filter removal.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Filter fracture of the wire is an uncommon, but known risk in relation to filter implant.However, in this case the filter fractured during retrieval.There is 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 complainant: the physician was removing an ivc filter that had been implanted in a patient for approximately 8 years by another physician and another unknown facility.It was noted that a main strut had broken off and is embedded in the ivc vena cava.The physician decided not to attempt removal and will be keeping an eye on the patient.Additional information, per the dm: "i spoke with dr again and he said the leg fractured during removal.The pt was having pain which is why he choose to remove the filter".Patient outcome: the fractured leg remains in the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5456159
• MDR Text Key: 39382634
• Report Number: 3002808486-2016-00044
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• 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
• Date Manufacturer Received: 01/28/2016
• 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): Other