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

Catalog Number IGTCFS-65-JUG-CELECT-PERM

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: ivc filter retrieval.Device was original cook celect ivc filter."a fracture had occurred at an unknown time after filter placement.Filter placement occurred in 2010.A single primary strut was found fractured.It sat perforating the ivc just below the main body of the filter.Patient was asymptomatic so the decision was made to leave the fractured strut as to not make the situation worse.The main body of the filter was successfully retrieved." patient outcome: a unintended section of the device remain inside the patient¿s fractured strut according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

Description of event according to medwatch report: "pt.Had ivc filter placed (b)(6) 2010.Recent radiology tests performed showed ivc filter fracture and perforation of one strut into infrarenal aorta.Ivc filter with 3 remaining primary struts intact and 8 secondary struts removed via interventional radiology procedure (b)(6) 2019.1 strut retained in infrarenal aorta (extraluminal) due to high risk of hemorrhage if removed.Per request of patient, explanted filter sent to (b)(6)." additional information received 17oct2019 from risk manager: "implant date was (b)(6) 2010".

Manufacturer Narrative

Manufacturers ref# (b)(4).G5) pma/510(k) p171712.H6) according to medwatch report: device code: 1104 (c63243).Investigation is still in progress.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

Manufacturers ref# (b)(4).Summary of investigational findings: a filter implanted in 2010 fractured during the implantation period.A single primary filter leg was found fractured and sat perforating the ivc just below the main body of the filter.The patient was asymptomatic, so the user decided to leave the fractured leg in order to not worsen the situation.The main body of the filter was retrieved successfully with interventional radiology procedure in 2019.No adverse effects on the patient was reported due to this occurrence.The dwell time is reported to be approximately 9 years, and during this period a primary filter leg fractured.A venogram, with the imaging date (b)(6) 2019, was reviewed in the complaint investigation.The image was a poor-quality screening shot from a venogram that demonstrates a celect filter in the infra-renal ivc.One of the primary filter legs was observed to be fractured, with the fracture fragment measuring just over 2 cm in length.The fractured fragment was located caudal to the body of the filter and directed perpendicular to the direction it should be oriented.The single image provided does therefore confirm a primary leg fracture as well as penetration.The retrieved filter was not returned for evaluation, and a device failure analysis could therefore not be conducted.However, it was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.There are adequate controls in place to ensure the device was manufactured to specifications.There was no discussion in the event description regarding the persistent clinical need of the filter for the 9-year duration to determine if the filter could have been removed earlier, potentially avoiding this complication.However, the exact cause for why the filter fractured during the implantation period is unknown.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9127386
• MDR Text Key: 165759144
• Report Number: 3002808486-2019-01549
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2012
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2617972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 62 YR
• Patient Weight: 59