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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220A
Device Problem Unintended Movement (3026)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Cellulitis (1768); Embolus (1830); Nausea (1970); Perforation of Vessels (2135); Vomiting (2144); No Code Available (3191)
Event Date 09/01/2017
Event Type  Injury  
Manufacturer Narrative

The product remains implanted and is thus not available for analysis. Additional information is pending and will be submitted within 30 days upon receipt. Concomitant medical products: unknown #15-blade scalpel. Unknown 5-mm retractor. Unknown 45-mm stapler. Unknown 30-french bougie. Unknown foley catheter 2 way 5 cc.

 
Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant an optease permanent vena cava filter for the treatment for a deep vein thrombosis (dvt) and pulmonary embolisms. The device was implanted into the patient¿s l2-l3 level of the renal vein. The device in the patient was positively identified by medical records. As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects. As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body. Additional information contained in the patient profile form (ppf) indicated that the filter has migrated, there are blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and the device is unable to be retrieved. The patient also reports to be suffering from mental anguish, depression, poor circulation, blood clot, cellulitis, transverse myelitis, extreme bloating. The indication for the implant was super morbid obesity with adhesions and scheduled for a laparoscopic gastric bypass with 120-cm roux-y limb and intraoperative upper gastrointestinal fluoroscopy. Extensive lysis, of adhesions. The filter was implanted via the right femoral vein and deployed at the l2-l3 interspace. Approximately two months after the filter was implanted the patient underwent an esophagogastroduodenoscopy for complaints of nausea and vomiting with abdominal pain. The test noted diffuse distension in the gastric pouch and extensive inflammation and mild ulceration in the anastomosis. An obstructive series performed the day prior showed a prior cholecystectomy and the presence of a ivc filter, there was no evidence for ileus or obstruction.

 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel
cahir road
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel
co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7381128
MDR Text Key103804799
Report Number9616099-2018-02031
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2007
Device MODEL Number466F220A
Device Catalogue Number466F220A
Device LOT NumberR0904445
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/31/2018
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/29/2018 Patient Sequence Number: 1
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