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

Catalog Number UNKNOWN

Device Problems Fracture (1260); Component Missing (2306)

Patient Problems Inflammation (1932); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since catalog number is unknown it could be either k061815, k073374, k090140, k112119, k121057 or k121629.Investigation is still in progress.

Event Description

Per article "safe endovascular retrieval of a vena cava filter after duodenal and pancreatic perforation and associated recurrent pancreatitis", john m.Green, m.D.Et al: insertion of a vena cava filter secondary to a contraindication to anticoagulation.She subsequently underwent a 6-month course of warfarin therapy several weeks after the contraindication resolved.Workup included an abdominal ct scan, and upper gastrointestinal endoscopy, that demonstrated vena cava filter struts perforating into the pancreas and the duodenal lumen.After 12 months of continued symptoms, she was referred for consideration of surgical removal of the vena cava filter.After consultation, the patient decided to pursue an endovascular retrieval.A dual 12- and 7-f sheath system was advanced into the inferior vena cava, and a contrast cavagram was performed showing strut perforation outside of the contrast column.After several attempts, the hook was ensnared with a multiloop snare.A flexible endoscope was passed into the duodenum, and the filter was removed from the vena cava with direct visualization of the duodenum and no occurrence of bleeding.A post-retrieval cavagram was performed showing no extravasation of contrast.On back-table examination, the filter was found to be fractured with a missing major strut.Prior abdominal x-rays demonstrated this fracture had occurred months earlier and revealed the strut was imbedded in the right iliac vein and was of no clinical consequence.The filter had been in situ for 1,610 days.Patient outcome: the major strut was imbedded in the right iliac vein and was of no clinical consequence.The patient was required to have the filter removed due to this happening.The patient experienced pancreatitis due to this occurrence.

Manufacturer Narrative

(b)(4).Catalog# unknown as information was not provided.Lot# unknown as information was not provided.Expirations date: unknown as information was not provided.Since catalog # is unknown it could be either k061815, k073374, k090140, k112119, k121057 or k121629.Summary of investigational findings: a posterior primary leg had perforated duodenum and an anterior primary leg had fractured.Most likely the fractured leg was not the perforating posterior primary leg.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.Also, fracture of the wire is a known risk in relation to filter implant reported in the published scientific literature.Rpn and lot number were not provided, why device history record cannot be investigated.However, there is 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 medical will continue to monitor for similar events.

Event Description

Per article "safe endovascular retrieval of a vena cava filter after duodenal and pancreatic perforation and associated recurrent pancreatitis", (b)(6), m.D.Et al: insertion of a vena cava filter secondary to a contraindication to anticoagulation.She subsequently underwent a 6-month course of warfarin therapy several weeks after the contraindication resolved.Workup included an abdominal ct scan, and upper gastrointestinal endoscopy, that demonstrated vena cava filter struts perforating into the pancreas and the duodenal lumen.After 12 months of continued symptoms, she was referred for consideration of surgical removal of the vena cava filter.After consultation, the patient decided to pursue an endovascular retrieval.A dual 12- and 7-f sheath system was advanced into the inferior vena cava, and a contrast cavagram was performed showing strut perforation outside of the contrast column.After several attempts, the hook was ensnared with a multiloop snare.A flexible endoscope was passed into the duodenum, and the filter was removed from the vena cava with direct visualization of the duodenum and no occurrence of bleeding.A post-retrieval cavagram was performed showing no extravasation of contrast.On back-table examination, the filter was found to be fractured with a missing major strut.Prior abdominal x-rays demonstrated this fracture had occurred months earlier and revealed the strut was imbedded in the right iliac vein and was of no clinical consequence.The filter had been in situ for 1,610 days.Patient outcome: the major strut was imbedded in the right iliac vein and was of no clinical consequence.The patient was required to have the filter removed due to this happening.The patient experienced pancreatitis due to this occurrence.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5096773
• MDR Text Key: 26517221
• Report Number: 3002808486-2015-00111
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• 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 Age: 42 YR