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

Catalog Number UNKNOWN

Device Problem Structural Problem (2506)

Patient Problem Great Vessel Perforation (2152)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Investigation is still in progress.

Event Description

According to initial reporter.During a filter retrieval at an obl i originally thought the filter was an option elite, but upon further evaluation, it appears to be a cook celect (not platinum) that was implanted 10 years ago.The filter has significant penetration through the ivc wall and abutted the aorta, we were unable to retrieve it and a second attempt will be made at the hospital with forceps and if unsuccessful, the patient will be referred to a specialist.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A second attempt will be made at the hospital with forceps and if unsuccessful, the patient will be referred to a specialist.

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# (b)(4).Summary of investigational findings: it was reported that a celect filter implanted approximately 10 years ago was attempted to be retrieved.The filter was observed with significant penetration through the ivc wall and abutted the aorta, so the physician was unable to retrieve the filter and a second attempt will be made later with forceps.A single fluoroscopic image from the attempted filter retrieval was provided and an imaging review was provided.Per the complaint report, the celect ivc filter was placed approximately 10 years ago.The indication for filter placement was not included in complete report, nor were the images from the initial placement.The single image submitted for review demonstrates a celect ivc filter presumably in the ivc with a large sheath positioned via the jugular approach and a glidewire loop snare created through the legs of the ivc filter.This is considered an advanced filter retrieval technique and was likely utilized due to the inability to grasp the hook of the ivc filter.The primary filter legs appear markedly splayed up to 59 mm indicating that they have likely perforated through the wall of the ivc.There is also a significant leftward tilt of approximately 20 °.Despite utilization of this advanced technique, per the complaint report, the filter retrieval was not successful, likely at least partially due to the penetration and the tilt/angle of the filter.Unfortunately, without the placement images, it is difficult to determine if the tilt was present at time of initial placement, which would have significantly contributed to the development of penetration, or if the tilt and penetration developed over time.At this point, the cause of penetration, is indeterminate.Filter penetration may be either symptomatic or asymptomatic and 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.Importantly, an additional filter retrieval will be attempted using endobronchial forceps in the future, per the complaint report, as leaving the filter in this configuration may result in the future problems related to perforation and/or filter fracture due to altered stresses placed on the filter.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.According to the instruction for use potential adverse events includes vena cava perforation there are adequate controls in place to ensure that this type of filter is manufactured to specifications.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.

Manufacturer Narrative

Manufacturers ref # (b)(4).Summery of investigational findings: it was reported that a celect filter implanted approximately 10 years ago was attempted to be retrieved.The filter was observed with significant penetration through the ivc wall and abutted the aorta, so the physician was unable to retrieve the filter and a second attempt will be made later with forceps.A single fluoroscopic image from the attempted filter retrieval was provided and an imaging review was provided.Per the complaint report, the celect ivc filter was placed approximately 10 years ago.The indication for filter placement was not included in complete report, nor were the images from the initial placement.The single image submitted for review demonstrates a celect ivc filter presumably in the ivc with a large sheath positioned via the jugular approach and a glidewire loop snare created through the legs of the ivc filter.This is considered an advanced filter retrieval technique and was likely utilized due to the inability to grasp the hook of the ivc filter.The primary filter legs appear markedly splayed up to 59 mm indicating that they have likely perforated through the wall of the ivc.There is also a significant leftward tilt of approximately 20 °.Despite utilization of this advanced technique, per the complaint report, the filter retrieval was not successful, likely at least partially due to the penetration and the tilt/angle of the filter.Unfortunately, without the placement images, it is difficult to determine if the tilt was present at time of initial placement, which would have significantly contributed to the development of penetration, or if the tilt and penetration developed over time.At this point, the cause of penetration, is indeterminate.Filter penetration may be either symptomatic or asymptomatic and 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.Importantly, an additional filter retrieval will be attempted using endobronchial forceps in the future, per the complaint report, as leaving the filter in this configuration may result in the future problems related to perforation and/or filter fracture due to altered stresses placed on the filter.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.According to the instruction for use potential adverse events includes vena cava perforation.There are adequate controls in place to ensure that this type of filter is manufactured to specifications.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12279225
• MDR Text Key: 265142416
• Report Number: 3002808486-2021-01676
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention