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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Occlusion Within Device (1423); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Catalog#: unknown but referred to as an ivc filter.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries." patient outcome: alleged that [pt] "have suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] have suffered emotional trauma, harm and injuries that will continue into the future.[pt] have lost their ability to live a normal life, and will continue to be so diminished into the future.Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects." hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4).Catalog#: unknown but referred to as an ivc filter.Expiration date: unknown as lot# is unknown.Explant date unknown as information was not provided.Approx.Age of device: unknown as lot# is unknown.Name and address for importer site: cook medical incorporated (cmi) (b)(4).Pma 510(k): since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfg date: unknown as lot# is unknown.(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 after further information is received and will supplement in accordance with 21 c.F.R.803.56 when appropriate.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries." patient outcome: alleged that [pt] "have suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] have suffered emotional trauma, harm and injuries that will continue into the future.[pt] have lost their ability to live a normal life, and will continue to be so diminished into the future.Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects." hospital and medical records have been requested but not yet provided.
 
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 31/jan/2018 as follows: patient received an implant on (b)(6) 2007 via the left common femoral vein due to deep vein thrombosis.Patient is alleging pain in groin, subdural hematoma, the filter is dislodged, pe and clogged filter.
 
Manufacturer Narrative
Manufacturer reference # (b)(4).Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (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 ¿ivc filter - pain in groin, subdural hematoma, migration, pe, ivc occlusion".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.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.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported pain in groin and subdural hematoma are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Filter type and lot# are unknown.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 reference # (b)(4).Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported pain in groin and subdural hematoma are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Filter type and lot# are unknown.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.
 
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Brand Name
UNKNOWN
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key6401723
MDR Text Key69840270
Report Number3002808486-2017-00805
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Distributor Facility Aware Date02/28/2017
Date Manufacturer Received02/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight95
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