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

Model Number G52917

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tachycardia (2095)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510(k) k172557.(b)(4).Investigation is still in progress.

Event Description

Description of event according to study: on (b)(6) 2018, subject became tachycardic during filter retrieval attempt.Heart rates (hr) were seen up to the 120-130s.Subject gradually improved while in the ir suite.Hr came down to in the low 100's.Filter retrieval attempt on (b)(6) 2018, resulted in severe pain of subject.Post-procedure pain rating was documented at a 9 on a 10 point scale.Subject responded well to pain medication while in the ir suite.On (b)(6) 2018, subject became hypoxic during filter retrieval attempt.Desaturation down to the high 80s, while also becoming tachycardic.O2 saturation improved above 92% with 6l nc.Pe was presumed and patient was anticoagulated with 5000 units of heparin.Chest x-ray (cxr) later revealed negative for pe, however cxr was suggestive of air trapping.O2 sat.Gradually improved while in the ir suite, saturating greater than 96% on 2l pm and hr lowered down to the low 100s.Patient outcome: the event resolved without sequelae and the subject was discharged on (b)(6) 2018.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on the event description only.It was reported that the patient experienced pain and became hypoxic and tachycardic during filter retrieval.Assuming the filter was successfully retrieved, as the event resolved without sequelae and the patient was discharged.No product was returned and no imaging was available and based on the limited information provided it would be inappropriate to speculate at what may or may not have caused the difficulties in retrieving the filter and the patient to experience pain and become hypoxic and tachycardic during attempted filter retrieval.It is noted that the filter was placed due to lle dvt and plans for excision of pelvic mass, but according to the instructions for use the tulip filter is intended for prevention of recurrent pe, if anticoagulant therapy has failed or is contraindicated.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.There are adequate controls in place to ensure that this type of device is manufactured to specifications.It was assessed that because no non-conformances were detected, there is 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.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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: GUNTHER TULIP NAVALIGN 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: 8815327
• MDR Text Key: 151851923
• Report Number: 3002808486-2019-01034
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)210501(10)E3720238
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E3720238
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 07/03/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 27 YR