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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM-CELECT-PERM
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Internal Organ Perforation (1987); Vomiting (2144); Cramp(s) (2193); No Information (3190)
Event Date 09/08/2011
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010". 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

Manufacturer reference # (b)(4). Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

This additional information received on 08/01/2017 as follows: patient allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to left iliofemoral deep vein thrombosis. Patient is alleging device migration and tilt and organ perforation due to the device. Patient alleges surgical explanation to remove the filter, resulting in knotted intestines, intestinal hardening, cramping, difficulty digesting food, and vomiting due to the device. Patient alleges attempted retrieval on (b)(6) 2011 and (b)(6) 2011 and that the filter was surgically retrieved 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 'migration,tilt,organ perf,surgical removal,knotted intestines, intestinal hardening,cramping,digestion problems'. 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. 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. 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

Investigation: investigation is reopened due to additional information provided. Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion. Therefore, no new investigation activities will be conducted at this time. Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. (b)(4) devices in lot. No relevant notes on work order. The product is manufactured and inspected according to specifications. 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. This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information becomes available.

 
Event Description

No additional information has been received regarding this event.

 
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Brand NameCOOK CELECT FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key6652854
MDR Text Key77914398
Report Number3002808486-2017-01314
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup
Report Date 04/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/29/2017
Device Age1 yr
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/01/2010
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: 06/20/2017 Patient Sequence Number: 1
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