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Catalog Number UNKNOWN
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597)
Event Type  Injury  
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 ¿vena cava perforation, device is unable to be retrieved, bleeding, organ perforation, stomach pain and anxiety". 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 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. Unknown if the reported bleeding, stomach pain, and anxiety are 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.
Manufacturer Narrative
(b)(4). Lot #: unknown. Catalog #: unknown but refered to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. Mfr date unknown as lot# is unknown. 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) 2011 at (b)(6) medical center. " 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 (b)(4). William cook europe aps (manufacturer) is submitting this report on behalf of (b)(4). (b)(4). (b)(6). The event is currently under investigation. A supplemental report will be provided upon conclusion.
Event Description
This additional information received on 08/15/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2011 via the femoral vein due to high risk of anticoagulation post spinal fusion for renal cell carcinoma. Plaintiff is alleging vena cava perforation, device is unable to be retrieved, bleeding, organ perforation, stomach pain, and anxiety.
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Manufacturer (Section D)
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
MDR Report Key5793275
MDR Text Key247117761
Report Number3002808486-2016-00706
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/06/2016
Event Location No Information
Date Manufacturer Received09/11/2017
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: 07/14/2016 Patient Sequence Number: 1