MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-FEM

Device Problems Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Perforation of Vessels (2135); Anxiety (2328); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference# #3002808486-2020-00486.Additional information provided determined that this device was manufactured by cook inc (cinc).With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number of this initial medwatch report.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: fracture , vena cava/organ perforation, embedment, filter erosion, bleeding, swelling, scarring, pain, emotional distress, anxiety, fear, physical limitations, kidney infections and sepsis.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.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.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 filter erosion, bleeding, swelling, scarring, pain, emotional distress, anxiety, fear, kidney infections and sepsis and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 devices were manufactured in the reported 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 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 become available.

Event Description

Patient allegedly received an implant on (b)(6) 2010 due to a subdural hematoma.Patient is alleging vena cava perforation, fracture, bleeding, organ perforation.Patient further alleges swelling to left foot, post-surgical scarring, pain to surgical site, emotional distress, anxiety secondary to fear of embolic event , kidney infection and sepsis and physical limitations.(b)(6) 2018, successful open retrieval report: "on a recent ct, one of the inferior vena cava filter prongs was seen penetrating the duodenum.This was subsequently confirmed with upper gi endoscopy, which revealed the inferior vena cava filter prong to have penetrated through the wall of the second part of the duodenum and sticking inside the intestinal lumen"."as we were dissecting the third portion of the duodenum, we encountered an area of significant inflammation.Manual palpation of that area revealed that the filter prong appeared to come right in the middle of the inflammatory process.With caution we were able to mobilize the duodenum off of the inferior vena ava.There was dense inflammatory tissue in that area, but we were able to circumferentially mobilize the duodenum and identify the prong of the inferior vena cava filter that had eroded into that structure.We used the wire cutter to cut the prong and we then removed it from the duodenum.We placed 3 lembert sutures in order to seal the defect on the duodenal wall.We did not see any significant leak out of that segment"."two more prongs of the ivc filter that were protruding outside the wall of the cava were then cut with the wire cutter and removed"."we brought the sheath close to the superior aspect of the filter and we made multiple attempts to capture the hook.Our attempts failed even when we manually directed the hook of the filter towards the snare.We felt therefore that the superior aspect of the filter including the hook were embedded onto the cava wall"."we dissected the cava above and below the filer and obtained proximal and distal control"." we quickly realized that the entire filter was embedded in the wall covered by dense connective tissue circumferentially.We worked on freeing the prongs from the wall of the cava and we were able to do that.There was some back-bleeding from some lumbar veins." "we needed sharp dissection in order to remove the filter from that area.Once the filter was removed we closed the longitudinal venotomy in the anterior wall of the inferior vena cava with running 5-0 prolene suture." "w e then realized that there was a significant amount of bleeding from one of the areas where the prong was penetrating the vena cava wall.This required repair with interrupted 5-0 prolene sutures.We secured complete hemostasis at this pint.There was no significant narrowing of the lumen of the inferior vena cava.There was flow documented in the vessel once our repairs were complete".

Event Description

No additional information has been received since the last report was submitted.

Manufacturer Narrative

Summary of event: patient allegedly received an implant on (b)(6) 2010 due to a subdural hematoma.Patient is alleging vena cava perforation, fracture, bleeding, organ perforation.Patient further alleges swelling to left foot, post-surgical scarring, pain to surgical site, emotional distress, anxiety secondary to fear of embolic event, kidney infection and sepsis and physical limitations.(b)(6) 2018, successful open retrieval report: "on a recent ct, one of the inferior vena cava filter prongs was seen penetrating the duodenum.This was subsequently confirmed with upper gi endoscopy, which revealed the inferior vena cava filter prong to have penetrated through the wall of the second part of the duodenum and sticking inside the intestinal lumen"."as we were dissecting the third portion of the duodenum, we encountered an area of significant inflammation.Manual palpation of that area revealed that the filter prong appeared to come right in the middle of the inflammatory process.With caution we were able to mobilize the duodenum off of the inferior vena ava.There was dense inflammatory tissue in that area, but we were able to circumferentially mobilize the duodenum and identify the prong of the inferior vena cava filter that had eroded into that structure.We used the wire cutter to cut the prong and we then removed it from the duodenum.We placed 3 lembert sutures in order to seal the defect on the duodenal wall.We did not see any significant leak out of that segment"."two more prongs of the ivc filter that were protruding outside the wall of the cava were then cut with the wire cutter and removed"."we brought the sheath close to the superior aspect of the filter and we made multiple attempts to capture the hook.Our attempts failed even when we manually directed the hook of the filter towards the snare.We felt therefore that the superior aspect of the filter including the hook were embedded onto the cava wall"."we dissected the cava above and below the filer and obtained proximal and distal control"." we quickly realized that the entire filter was embedded in the wall covered by dense connective tissue circumferentially.We worked on freeing the prongs from the wall of the cava and we were able to do that.There was some backbleeding from some lumbar veins." "we needed sharp dissection in order to remove the filter from that area.Once the filter was removed, we closed the longitudinal venotomy in the anterior wall of the inferior vena cava with running 5-0 prolene suture." "we then realized that there was a significant amount of bleeding from one of the areas where the prong was penetrating the vena cava wall.This required repair with interrupted 5-0 prolene sutures.We secured complete hemostasis at this point.There was no significant narrowing of the lumen of the inferior vena cava.There was flow documented in the vessel once our repairs were complete".Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.The tulip filter was returned with only one intact secondary leg/blade.The remaining legs had fractured but were all returned.All the breaking points were analyzed by scanning electron microscope, but no inclusion or other material imperfections could be found.Due to angled surfaces and smearing of the material, the analysis merely suggested that the legs were cut.A document-based investigation-evaluation was conducted.No non-conformances were found on the lot.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in-house or in the field.The product ifu warns that acute damage to the inferior vena cava is a potential adverse event.Based on the information provided and the results of the investigation, cook has concluded that the exact reason for the filter to perforate the vena cava during the 8 years dwell time cannot be determined.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10167760
• MDR Text Key: 200996824
• Report Number: 1820334-2020-01147
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

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 Expiration Date: 06/01/2013
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2526003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2010
• 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): Life Threatening
• Patient Sex: Female
• Patient Weight: 68 KG