• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problems Erosion (1750); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional. (b)(4). Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date. Filter or filter fragment migration and (or) embolization (e. G. , movement to the heart or lungs) has been reported. Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic. Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; and (or) excessive force or manipulations near an in situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: filter migration, trauma to adjacent structures. Filter fracture has been reported and may be either symptomatic or asymptomatic. Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e. G. , a renal vein). Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported. Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures. Vena cava wall penetration/perforation has been reported and may be either symptomatic or asymptomatic. Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration. Filter tilt has been reported. Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt. Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency. Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt. Unknown if the reported ivc erosion and pain post implant are directly related to the filter and unable to identify a corresponding failure mode at this point in time. Unknown if the reported pain is directly related to the filter and unable to identify a corresponding failure mode at this point in 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. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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) 2010. Alleged fracture, perforation, tilt and ivc erosion. " patient allegedly received an implant on (b)(6) 2010 via right common femoral vein due to deep vein thrombosis (per implant operative report). Patient is alleging fracture, perforation, tilt, ivcf erosion and pain. Per a ct (computed tomography) scan of the abdomen and pelvis dated (b)(6) 2014, ¿an inferior vena cava filter is noted. The filter is tilted towards the left. ¿ per a ct (computed tomography) scan of the abdomen and pelvis dated (b)(6) 2017, ¿ivc filter with numerous limbs extending beyond the walls of the ivc. One of the limbs is now fractured and residing in the right retroperitoneum. An additional limb comes in very close proximity to the proximal right ureter. Another limb rests along the anterior wall of the abdominal aorta. Impression. " patient outcome: alleged "pain post implant, and ivc erosion. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key9232382
MDR Text Key177286556
Report Number3002808486-2019-01734
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
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 Initial

Patient TREATMENT DATA
Date Received: 10/24/2019 Patient Sequence Number: 1
-
-