MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS GUNTHER TULIP IVC FILTER; FILTER, INTRAVASCULAR CARDIOVASCULAR

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/13/2018

Event Type  Injury  

Event Description

During an ivc filter retrieval, when the filter was removed and examined, it was noticed that a small piece of one of the struts was missing.Dr looked under fluoro and the piece appeared imbedded in the vessel wall.The filter had been initially implanted in 2006.

• Brand Name: GUNTHER TULIP IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE APS
• MDR Report Key: 7922262
• MDR Text Key: 122307225
• Report Number: MW5080206
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR