MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52918

Device Problems Bent (1059); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: device was placed via femoral approach.Once the filter was unsheathed, it was noted that the secondary struts were bent.The filter was removed with a gtrs-200-rb via jugular approach.A second igtcfs-65-1-uni-tulip was placed to successfully complete the procedure.Patient outcome: the device did cause or contribute to the need for additional procedures: the device was removed and another device was placed.

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).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.H11)corrected data from medwatch (b)(4): a5a: not hispanic.A5b: white.B3: (b)(6) 2018.B4: jun 2018.B7: preexisting characteristics that may have contributed to the event: d1: gunther tulip.D2: filter, intravascular, cardiovascular.D3: cook inc bloomington, in.D4: g52918.Expdate: feb 2021.D6: (b)(6) 2018.D7: (b)(6) 2018.E1: (b)(6).E2: yes.E3: risk manager.F14: cook inc 750 daniels way bloomington, in 47402.Summary of investigational findings: the complete device was returned.The filter was found severely damaged, with all secondary filter legs displaced towards the filter hook and dents were noted on the sheath tip.The complaint report does not describe any abnormal maneuvers that may have resulted in this situation but rather states "once the filter was unsheathed, it was noted the secondary struts were bent." although not explicitly stated, the most likely explanation is the filter was initially deployed by retraction of the sheath, however, the sheath was either purposefully or inadvertently re-advanced over the ivc filter, resulting in the cranial displacement of the junction of the primary and secondary legs causing the configuration observed.Fortunately, the secondary arm abnormality was recognized by the deploying physician and the filter was removed via a jugular approach and replaced.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.Cook medical will continue to monitor for similar events.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 Description

Additional information received 27jun2018: "upon positioning the device within the patient, it was noticed the filter was damaged/misshapen.The support legs of the filter were bent in an upward position.When this was noticed, the filter was unable to be removed.The filter was then deployed in the inferior vena cava.After this the doctor then retrieved this filter from a jugular approach.After the retrieval was successfully performed, another filter was placed into the inferior vena cava without difficulty.".

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7439071
• MDR Text Key: 105754345
• Report Number: 3002808486-2018-00461
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)210221(10)E3692849
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E3692849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Distributor Facility Aware Date: 04/03/2018
• Device Age: 1 MO
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 75