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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problems Structural Problem (2506); Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Catalog # is unknown but referred to as tulip.Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged tulip is manufactured and inspected according to specifications.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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2019, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, b7, d1, d4, g4, h4, h6 (patient and device codes) g4 (pma/510k): k172557 investigation: the following allegations have been investigated: vena cava (vc) perforation, bleeding, hematoma, pain, fatigue, nausea, depression, anxiety, post traumatic stress disorder (ptsd), insomnia, fear, disability, physical limitations.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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 bleeding, hematoma, pain, fatigue, nausea, depression, anxiety, post traumatic stress disorder (ptsd), insomnia, fear, disability, and physical limitations directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.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.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received an implant on (b)(6) 2019 via the right common femoral vein post pulmonary embolism (pe).Patient is alleging vena cava perforation and bleeding.Patient notes and further alleges experiencing "pain in back, fatigue, nausea, cannot sit/stand/lay down without excruciating pain", depression, anxiety and ptsd, unable to sleep, fear, inability to work, disability.Per a computed tomography (ct)abdomen pelvis without contrast: "findings: there is redemonstration of a pericaval hematoma at the level of previously placed ivc filter"."impression: retroperitoneal pericaval hematoma is demonstrated measuring 7.4 x 2.2 x 4 cm on the current examination.Previously, at the same level, this measured 8 x 2.3 x 4.1 cm allowing for limitations due to lack of intravenous contrast.There is a component of the hematoma which extends along the right pelvic sidewall and towards the inferior pole of the right kidney which appears slightly progressed from prior examination".Per a ct abdomen pelvis without contrast: "1.Previous demonstrated hematoma appears essentially stable, and in some areas such as a retrocaval region, perhaps slightly less prominent when compared to the prior examination.Overall, the hematoma appears better organized with more defined margins when compared to the prior examination.No acute osseous findings are seen.2.Ivc filter is again seen and appear stable from the prior examination.An anterior leftward footplate pierces through the ivc wall which is unchanged from the prior examinations".Per a ct abdomen pelvis without contrast: "redemonstration of a infrarenal ivc filter.Previously described retrocaval hematoma has decreased in size in the interval measuring approximately 7.3 by 1.7 x 1.4 cm in greatest dimensions on the current exam compared to 8.5 by 2.4 x 1.7 cm on prior exam.Is also less dense compared to prior exam".

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• MDR Report Key: 11584550
• MDR Text Key: 242805617
• Report Number: 3002808486-2021-01034
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3489154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 147