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

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided catalog is unknown but referred to as cook celect filter expiration date: unknown as lot# is unknown name and address for importer site: (b)(4).Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: it is alleged that "on or about (b)(6) 2015, [pt] was implanted with a cook celect filter." on or about (b)(6) 2016, [pt] underwent a retrieval of her ivc filter, which was complicated by myocardial perforation and resulted in pericardial effusion.Patient outcome: it is alleged that: "as a result of the damage to her heart, [pt] faces numerous health risks, including the risk of death.[pt] will require ongoing medical monitoring for the rest of her life.[pt] has suffered and will continue to suffer serious physical injuries, pain and suffering, mental anguish, medical expenses, economic loss, loss of enjoyment of life, disability, and other losses" hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: it has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.Cook medical will continue to monitor for similar events.

Manufacturer Narrative

Exemption number e2016032e lot.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

This additional information received on 9feb2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2015 via the right internal jugular vein due to pulmonary embolism.[pt] is alleging organ perforation.[pt] further alleges daily pain in the heart due to the perforation/trauma to heart during the removal of the ivg filter, daily pain in stomach after eating a meal.On (b)(6) 2016 filter was successfully retrieved and the retrieval was complicated by complicated by myocardial perforation.

Manufacturer Narrative

Exemption number: e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Mfr site: name and address for importer site: (b)(4).Additional information: investigation: investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect, vc perforation, diff.To retrieve, chest / stomach pain, health risks'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported health risks are directly related to the filter and unable to identify corresponding failure mode(s) at this time.Rpn and lot# are unknown, but the celect filter 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.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.

Manufacturer Narrative

Manufacturer ref# pr184609 summary of investigational findings: complaint re-investigated since medical records were provided.Organ perforation and daily pain in the heart due myocardial perforation during the filter removal approx.One year after placement.A cook celect ivc filter was placed in the infra-renal location via a jugular approach.Based on the radiopaque sheath tip, the infrarenal ivc measures approximately 19.6 mm in diameter.The ivc runs parallel to the posterior spinous processes.The inflow from the renal veins is vaguely appreciated at the l1 vertebral body.Relative to the posterior spinous processes there is an 8.3° of leftward tilt present.The maximal distance between the primary filter feet measures 25.3 mm.All 4 primary filter feet are clearly identified.The resolution is such that all 8 of the secondary filter legs are not clearly seen.There were grade 1 interactions with the wall of the ivc indicating tenting, but no evidence of penetration on follow up ct scan performed ~ 2 weeks after placement.7 months after placement, there is now leftward tilt of 16° and mild widening of the primary filter feet measuring up to 36.5 mm in maximal dimension.Without cross-sectional imaging, there is no way to determine if the primary filter legs have penetrated through the wall of the ivc or if this is just progressive tenting of the ivc.Given the previous dimension of the ivc, the primary filter legs do likely extend through the wall of the ivc, but this cannot be confirmed on the submitted images.Determining the strongest contributing factor to the development of penetration is no definite, but given the initial and progressive tilt, this may have been the predominant cause of the penetration.There was no discussion in the complaint report regarding any predisposing or compounding factors that may have contributed to worsening tilt, such as a major abdominal surgery with manipulation of the ivc.Approx.One year after filter placement the patient underwent a retrieval of the ivc filter, which was ¿complicated by a myocardial perforation and resulted in a pericardial effusion." no images of the retrieval were submitted for review to evaluate how the purported myocardial perforation occurred.The only images submitted for review from this date include a four-quadrant ultrasound of the abdomen which demonstrates no evidence of free fluid and a portable chest x-ray.The portable chest x-ray does demonstrate prominence of the cardiac silhouette, which may be accentuated due to the low lung volumes as well as the portable technique, however, a pericardial effusion can cause this appearance on the x-ray, and therefore cannot be entirely excluded.There are no cross-sectional or ultrasound images demonstrating the presence of a pericardial effusion to confirm this suspicion, however, there was a cardiac echo report in the medical records describing a pericardial effusion and clot.The medical report from the retrieval event also states that imaging was performed which ¿revealed pericardial effusion/clot concerning for myocardial perforation/trauma, likely due to the filter retrieval sheath¿.The procedure details describe a straightforward filter retrieval and do not describe any events that could have reasonably led to a myocardial perforation.The physician does not elaborate on how the retrieval sheath could have caused the myocardial perforation.The patient was anticoagulated at time of ivc filter retrieval with an inr recorded at 1.75.This may have contributed to amount of the bleeding into the pericardial space that occurred.The medical records also state patient underwent a pericardial window to treat the pericardial effusion, but the operative report from this procedure was not provided.A follow-up chest x-ray performed 3 months later demonstrates normal cardiac silhouette and a follow-up chest ct performed 5 months later demonstrates no evidence of pericardial effusion or cardiac abnormality.Follow-up ct scan of the abdomen and pelvis 9 months later demonstrates no findings to suspect ivc injury or any pericaval inflammation.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6607351
• MDR Text Key: 76494084
• Report Number: 3002808486-2017-01166
• 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,Followup,Followup
• Report Date: 04/15/2020

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/11/2017
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 10/27/2017; 02/09/2018; 03/21/2018; 04/07/2020
• Supplement Dates FDA Received: 11/22/2017; 03/08/2018; 04/10/2018; 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 126