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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Edema (1820); Pain (1994); Perforation of Vessels (2135); No Information (3190)

Event Date 09/29/2011

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Catalog is unknown but referred to as gunther tulip filter.(b)(6).Investigation is still in progress.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter in (b)(6) 2011." 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

Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.  cook will reopen its investigation if further information is received.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 30/jan/2018 as follows: patient received an implant on (b)(6) 2011 via the right common femoral vein due to upcoming back surgery.Patient is alleging migration, edema, anxiety, leg pain, device unable to be removed.Retrieval was attempted on (b)(6) 2011.

Manufacturer Narrative

Manufacturer reference # (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 'tulip, migration, tilt, vc perforation, edema, anxiety, leg pain, unable to remove, embedded'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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 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.Unknown if the reported edema, anxiety, leg pain is directly related to the filter and unable to identify corresponding failure mode(s) at this time.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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6586888
• MDR Text Key: 75815731
• Report Number: 3002808486-2017-01136
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2017
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR
• Patient Weight: 73