MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34309

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: when the physician tried to deploy the jugular filter, the secondary struts released but the primary struts were closed together.The physician took a cavagram prior to the procedure and observed no clots or seneekieye (synechia?) or other debris in the ivc.Physicians push a button to release struts, but the physician didn't see the struts were not all deployed before he released (wasn't apparent on imagery or the physician just didn't notice); after the filter was released the imagery showed that not all struts were released.At that point no repositioning could be attempted.The physician recaptured the filter with a filter retrieval device and, once they recaptured it (pulled into bottom of sheath) they tried to redeploy it (pushed it back out) and all the struts were correctly flared/deployed.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k) k171712.Summary of investigational findings: the investigation is based on the event description only.It was reported that the filter failed to fully expand - "secondary struts released but the primary struts stayed closed".Even after the filter failed to expand, the release button was pressed and "the imagery showed the struts not all released".The filter was recaptured with" filter retrieval device", which is assumed to be the jugular introducer, since it was reported that there was no need for an additional procedure.No harm to patient reported.It was determined that because any discovered non-conformances were properly dispositioned before qc release, there is objective evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded, that there is no evidence that nonconforming product exists in house or in field.No product was returned and no imaging was provided.Therefore, based on limited information received it would be inappropriate to speculate at what may or may not have caused the primary filter legs to be "closed together".However, it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.It is noted, that the "physician didn't see the struts" before releasing the filter, but according to ifu correct placement of the filter must be verified before releasing it.Also, it is noted that the filter was recaptured with the "filter retrieval device", pulled into the sheath and re-deployed.This replacement is assumed to be done with the grasping hook of the jugular introducer, since it was reported that the difficulties encountered did not require additional procedures.No evidence to suggest the product was not manufactured according to current specifications.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: 8695352
• MDR Text Key: 148304347
• Report Number: 3002808486-2019-00738
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220128(10)E3818382
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3818382
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/23/2019
• Device Age: 4 MO
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1