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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Hematoma (1884); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597)

Event Date 04/12/2013

Event Type  malfunction  

Manufacturer Narrative

Manufacturer reference pr# (b)(4). Exemption number e2016032. (b)(4). 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 'tilt, vena cava perforation, bleeding, retroperitoneal hematoma, severe 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 tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. 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.

Manufacturer Narrative

(b)(4). Catalog number: unknown but referred to as a cook celect filter. Since catalog number is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013 at (b)(6). " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

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

Event Description

This additional information received on 06/15/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the right femoral vein due to left femoral dvt. Plaintiff is alleging tilt, vena cava perforation, bleeding, retroperitoneal hematoma, and severe pain. Patient alleges successful retrieval on (b)(6) 2013.

• Brand Name: UNKNOWN
• 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: 5693788
• MDR Text Key: 248276277
• Report Number: 3002808486-2016-00371
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 05/31/2016
• Event Location: No Information
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/02/2016 Patient Sequence Number: 1