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

Model Number G52917

Device Problem Structural Problem (2506)

Patient Problems Death (1802); Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: non-healthcare professional.Pma/510(k) k172557.Summary of investigational findings: the following allegations have been investigated: vena cava (vc) perforation, physical limitations.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported physical limitations is 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2014." additional information received: patient allegedly received an implant via the right femoral vein due to deep vein thrombosis (dvt), pulmonary embolism (pe).Vena cava perforation is alleged as well as limitations to physical activity.On 0(b)(6) 2014, inferior vena cava (ivc) filter placement: "at this time, a 65-cm gunther tulip vena cava filter set was then introduced.Ivc filter was then inserted up to just below the renal veins.Ivc filter was ten deployed successfully under fluoroscopy".On (b)(6) 2014, ct chest, abdomen and pelvis with contrast: "ivc filter in place".On (b)(6) 2014, ct abdomen and pelvis with contrast: "ivc filter is in place".On (b)(6) 2015, ct chest with contrast: "an ivc filter is in place".On (b)(6) 2015 ct thorax (with contrast); ct abdomen/pelvis with contrast: "note is made of an ivc filter".On (b)(6) 2015 ct chest with contrast: "there is atherosclerotic calcification of the abdominal aorta and ivc filter in place".On (b)(6) 2016, ct chest with contrast: "ivc filter is again noted".On (b)(6) 2016, ct chest, abdomen and pelvis with contrast: "there is an infrarenal ivc filter in place".On (b)(6) 2016, ct thorax (with contrast); ct abdomen/pelvis with contrast: "note is made of an infrarenal ivc filter".(on b)(6) 2016, ct abdomen and pelvis with/without contrast: "there is an infrarenal ivc filter in place".On (b)(6) 2017, ct abdomen and pelvis with/without contrast: "an ivc filter is noted in place".On (b)(6) 2018, ct chest with contrast and ct abdomen/pelvis with/without contrast: "there is an ivc filter seen in good position".On (b)(6) 2018, ct2 thorax: "the filter struts have penetrated through the wall of the ivc into the pericaval/mesenteric fat".On (b)(6) 2018, ct chest: "there is an ivc filter in place at the level of the kidneys".Per certificate of death, date of death: (b)(6) 2019.Immediate cause of death: "metastatic high-grad serous ovarian carcinoma"."other significant conditions contributing to death but not resulting in the underlying cause.Hypertension, non-stemi myocardial infarction".Patient outcome: [pt] is deceased.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov 4632
• MDR Report Key: 10187799
• MDR Text Key: 201070725
• Report Number: 3002808486-2020-00649
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)170402(10)E3201103
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2017
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E3201103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening