MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JUG-CELECT-PERM

Device Problems Fracture (1260); Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. (b)(4). Investigation is still in progress.

Event Description

Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009. [pt] suffered and continues to suffer from pain was hospitalized as result of the filter, perforating, bending, twisting, fracturing, and is unable to be retrieved. The defective filter also allowed pe's to pass through and caused blood clots". Patient outcome: [pt] suffered and continues to suffer from pain and emotional distress.

Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k061815 or k073374. (b)(4). Summary of investigational findings: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. " vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Filter fracture is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. 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 initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009. [pt] suffered and continues to suffer from pain. Was hospitalized as result of the filter, perforating, bending, twisting, fracturing, and is unable to be retrieved. The defective filter also allowed pe's to pass through and caused blood clots". Patient outcome: [pt] suffered and continues to suffer from pain and emotional distress.

Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 02/24/2017 as follows: the patient allegedly received device implant on (b)(6) 2009 due to right lower extremity dvts and recurrent right lower lobe pes. The patient alleges that the device is twisted, bent, and potentially broken and allows for the passage of painful clots.

Manufacturer Narrative

(b)(4) corrected data based on new information received: adverse event and product problem to adverse event. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect, unable to be retrieved, bent, potentially broken, perforating, blood clots (pe), pain'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. Filter fracture is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e. G. Renal vein), excessive force or manipulations near an implanted filter (e. G. A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter. It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible. Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature. It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved. 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. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. 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.

• Brand Name: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 6192235
• Report Number: 3002808486-2016-01526
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 12/05/2016
• Event Location: No Information
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/29/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Weight: 118
• Patient Outcome(s): Life Threatening