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

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k073374, k090140, k112119, k121057 or k121629.Unknown as lot# is unknown.(b)(4).Investigation is still in progress.

Event Description

Description of event according to journal article "endovascular management of symptomatic gastrointestinal complications associated with retrievable inferior vena cava filters" by genovese et al: "symptomatic gastrointestinal complication; abdominal pain, elective filter removal, inability to capture filter hook; filter apex embedded in the caval wall, five times beyond caval wall, abutting aorta, l3, duodenum; no duodenal perforation.Filter retrieved successfully and were successfully discharged to rehabilitation facilities.Two years follow-up: improvement in abdominal pain, no long-term complications, no long-term anticoagulation." patient outcome: no unintended section of the device remained in the patient's body.Additional procedures required: exploratory laparotomy (midline incision), primary repair of bowel injury, venotomy and explantation of ivc filter; anticoagulation: dvt prophylaxis (subcutaneous heparin).Adverse events reported: symptomatic gastrointestinal complication and abdominal pain.

Manufacturer Narrative

Manufacturer ref# (b)(4).A1) unknown as information was not provided.A4) unknown as information was not provided.B3) unknown as information was not provided.D1) unknown as information was not provided.D4) lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.G5) since catalog# is unknown the 510(k) could be either k073374, k090140, k112119, k121057 or k121629.H4) unknown as lot# is unknown.(b)(4).Summary of investigational findings: no imaging was provided and therefore it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us concerning "abdominal pain, elective filter removal, inability to capture filter hook; filter apex embedded in the caval wall, five tines beyond caval wall, abutting aorta, l3, duodenum; no duodenal perforation." it is noted that the celect filter was successfully retrieved and that the abdominal pain had improved.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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 of event according to journal article "endovascular management of symptomatic gastrointestinal complications associated with retrievable inferior vena cava filters" by genovese et al: "symptomatic gastrointestinal complication; abdominal pain, elective filter removal, inability to capture filter hook; filter apex embedded in the caval wall, five tines beyond caval wall, abutting aorta, l3, duodenum; no duodenal perforation.Filter retrieved successfully and were successfully discharged to rehabilitation facilities.2 years follow-up: improvement in abdominal pain, no long-term complications, no long-term anticoagulation." patient outcome: no unintended section of the device remained in the patient's body.Additional procedures required: exploratory laparotomy (midline incision), primary repair of bowel injury, venotomy and explantation of ivc filter; anticoagulation: dvt prophylaxis (subcutaneous heparin).Adverse events reported: symptomatic gastrointestinal complication and abdominal pain.

• 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: 6131231
• MDR Text Key: 60989873
• Report Number: 3002808486-2016-01446
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 11/21/2016
• 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; Required Intervention
• Patient Age: 37 YR