MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Material Twisted/Bent (2981); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Abdominal Cramps (2543); No Information (3190)

Event Type  Injury  

Event Description

It is alleged that the patient received a gunther tulip on (b)(6) 2008.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2008 via right common femoral vein due to motor vehicle accident.Patient is alleging tilt and vena cava perforation.The patient further alleges ¿pain and cramping in lower stomach, constipation and back pain¿ as well as limited physical activity.Per a ct (computed tomography) scan of the abdomen dated (b)(6) 2019, ¿aberrant placement ivc filter with 25% degree tilting.Bent 1 o'clock strut.Perforated struts at 12 and 2 o'clock.¿.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged perforation.Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated.Vena cava (vc) perforation, bent, tilt, pain, cramping, constipation and limited physical activity.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported bent, pain, cramping, constipation, limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown, however, the device is manufactured and inspected according to current controls.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.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

The patient alleges organ perforation and ivc wall/bowel/aorta embedment.On (b)(6) 2019, per a report from computed tomography 2; ¿the hook of the cook gunther tulip retrievable ivc filter is at the l1-2 interspace.The ivc filter is severely tilted posteriorly and laterally and the hook is embedded within the ivc wall.One (1) anterior strut perforates the ivc wall 13mm and is embedded within the bowel.One (1) medial strut perforates the ivc wall 15mm and is embedded within the aorta.Thrombus within the ivc or filter cannot be evaluated on this non contrast study.No fracture fragments are identified.¿.

Manufacturer Narrative

Investigation: the following allegations have been investigated: organ perforation, ivc wall/bowel/aorta embedment, back pain.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation, ivc wall/bowel/aorta embedment does not change the previous investigation results for vena cava perforation.Unknown if the reported back pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown, however, the device is manufactured and inspected according to current controls.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.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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9022101
• MDR Text Key: 158108483
• Report Number: 1820334-2019-02294
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 10/25/2019; 01/19/2021
• Supplement Dates FDA Received: 11/13/2019; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 90