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

Model Number	G48378
Medical Device Problem Codes	Difficult to Remove (1528); Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/19/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).A2) unknown as information was not provided.A4) unknown as information was not provided.B3) unknown as information was not provided.D1) unknown as information was not provided.D4) lot#: unknown as information was not provided.Catalog is unknown but referred to as cook celect filter.Expiration date: unknown as lot# is unknown.F9) unknown as lot# is unknown.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.G5) since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.H4) unknown as lot# is unknown.(b)(4).Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter in (b)(6) 2012." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).(b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.H11) corrected data.B1) changed from adverse event to product problem.H1) changed from serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
This additional information received on 05/10/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2012 via the right femoral vein due to deep vein thrombosis.Plaintiff is alleging embedment and device is unable to be retrieved.Plaintiff alleges attempted retrieval on (b)(6) 2013.
Additional Manufacturer Narrative
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 "embedment and device is unable to be retrieved¿.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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: COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6590010
• Report Number: 3002808486-2017-01151
• Device Sequence Number: 95784
• Product Code: DTK
• UDI-Device Identifier: 00827002483781
• UDI-Public: (01)00827002483781(17)140711(10)E2946297
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G48378
• Device Catalogue Number: IGTCFS-65-UNI-CELECT-PERM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2017
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided; 09/14/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 05/24/2017; 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 70