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

Catalog Number UNKNOWN

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Edema (1820); Erythema (1840); Perforation (2001); Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

Catalog#: unknown but referred to as a günther tulip vena cava filter.Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.Investigation still in progress.(b)(4).

Event Description

Description according to article: asad jehangir et al "ivc filter perforation through the duodenum found after years of abdominal pain" a g܎ther tulip vena cava filter was placed prophylactically 5 years ago prior to decompressive laminectomy with bilateral foraminotomy and lumbar fusion for spinal stenosis.The patient was presented with several years of right upper quadrant abdominal pain which was exacerbated by movement and food intake.Esophagogastroduodenoscopy revealed a thin metallic foreign body embedded in the duodenal wall and protruding into the duodenal lumen with surrounding erythema and edema, but no active hemorrhage.Further evaluation with non-contrast ct scan revealed that one of the prongs of her ivc filter had perforated through the vena cava wall into the adjacent duodenum.Patient outcome: a section of the device did not remain inside the patient's body.The patient was required to have exploratory laparotomy for removal of ivc filter and repair of vena cava and duodenum.The patient's postoperative course was uneventful and the right upper quadrant pain completely resolved.

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a günther tulip vena cava filter.Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.Summary of investigational findings: imaging found that four primary legs had perforated ivc, and confirmed that one on them perforated adjacent organs, duodenum.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.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

Description according to article: (b)(6) et al "ivc filter perforation through the duodenum found after years of abdominal pain" a gunther tulip vena cava filter was placed prophylactically 5 years ago prior to decompressive laminectomy with bilateral foraminotomy and lumbar fusion for spinal stenosis.The patient was presented with several years of right upper quadrant abdominal pain which was exacerbated by movement and food intake.Esophagogastroduodenoscopy revealed a thin metallic foreign body embedded in the duodenal wall and protruding into the duodenal lumen with surrounding erythema and edema, but no active hemorrhage.Further evaluation with non-contrast ct scan revealed that one of the prongs of her ivc filter had perforated through the vena cava wall into the adjacent duodenum.Patient outcome: a section of the device did not remain inside the patient's body.The patient was required to have exploratory laparotomy for removal of ivc filter and repair of vena cava and duodenum.The patient's postoperative course was uneventful and the right upper quadrant pain completely resolved.

• 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: 5096776
• MDR Text Key: 26549547
• Report Number: 3002808486-2015-00114
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/26/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR