MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Initial reporter: contact information not provided.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, a female patient had a gianturco-roehm bird's nest femoral vena cava filter implanted in the inferior vena cava on (b)(6) 2005.A computed tomography (ct) was done (at another hospital) where it was discovered the implant had perforated or broken.Additional information was provided by the patient: the gianturco-roehm bird's nest femoral vena cava filter was found to have perforated the iliac artery and four prongs were broken.The portions have not been retrieved because, reportedly, it is too life-threatening at this point.The patient has reported a burning sensation in the abdomen and occasional pain in the upper legs.The patient has had (or possibly still has) kidney cancer and cirrhosis and has checkups every six months.Per the patient, (b)(4) is listed on the product card.Product and lot numbers are unknown.The complaint device remains implanted; therefore, is not available for return to the manufacturer.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.Reviews of the complaint history, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The device is shipped with instruction for use (ifu) which notes: that vena cava wall perforation is a known potential complication of vena cava filters.Perforation can be both asymptomatic and symptomatic.Causes of penetration/perforation of the vena cava may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter, and/or procedures that involve other devices being passed through an in situ filter.The ifu also warns against overly forcing or ¿jabbing¿ with the filter/catheter/introducer sheath assembly, which could lead to perforation of the wall of the vena cava with the exposed hooks and struts of the filter.Additionally, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded the event is a known inherent risk of the device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8546708
• MDR Text Key: 143040700
• Report Number: 1820334-2019-00931
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other