OPTEASE
Received Jul 13, 2026 · Event occurred Jun 19, 2026
Report 9616099-2026-00967 · MDR key 25796791
Device
Generic name
Filter, Intravascular, Cardiovascular
Manufacturer
Cordis Us. CorpCatalog number
466F210AF
Lot number
18475292
Product problems
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, DURING AN INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL PROCEDURE 10 DAYS POST IMPLANTATION OF A 55CM FEMORAL OPTEASE VENA CAVA (VC) FILTER, PREOPERATIVE ANGIOGRAPHY FOUND THAT THE FILTER HAD FRACTURED IN VIVO. THE MAIN BODY OF THE FILTER WAS REMOVED DURING THIS PROCEDURE; HOWEVER, THE FRACTURED BRANCH WAS REMOVED FROM THE PULMONARY ARTERY 3 DAYS FOLLOWING THE PLANNED FILTER RETRIEVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.