IMPEDE-FX EMBOLIZATION PLUG
Report
- Report Number
- 3013353964-2025-00008
- Event Type
- Malfunction
- Date Received
- June 19, 2025
- Date of Event
- May 20, 2025
- Report Date
- June 19, 2025
- Manufacturer
- SHAPE MEMORY MEDICAL, INC.
- Product Code
- KRD
- UDI-DI
- 00810041650054
- PMA / PMN Number
- K182390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
THE MANUFACTURING DOCUMENTATION FOR THE LOT ASSOCIATED WITH THIS DEVICE/INCIDENT COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. A BENCHTOP INVESTIGATION WAS NOT PERFORMED SINCE THE DEVICE WAS IMPLANTED IN THE PATIENT AND COULD NOT BE RETURNED TO SHAPE MEMORY MEDICAL INC. BASED ON SHAPE MEMORY MEDICAL'S REVIEW OF RECEIVED INFORMATION, IT WAS REPORTED BY THE SMM EMPLOYEE FAMILIAR WITH THE CASE THAT THE 5F SHEATH USED TO DELIVER THE IMP-FX-12 PLUG MAY HAVE NOT BEEN IN THE TARGET LOCATION (SMA DISSECTION). HOWEVER, WITHOUT ADDITIONAL INFORMATION, A ROOT CAUSE CANNOT BE DEFINITIVELY CONFIRMED. OTHER THAN THE SUSPECTED MIGRATION, THERE WAS NO DEVICE MALFUNCTION REPORTED AND THE 5F SHEATH USED DURING THE PROCEDURE IS NOT MANUFACTURED BY SHAPE MEMORY MEDICAL. ADDITIONALLY, THE IMPEDE-FX-US INSTRUCTIONS FOR USE, IFU1354-01 REV A, STATES THAT "PHYSICIANS SHOULD EXERCISE CLINICAL JUDGEMENT WHEN USING THE IMPEDE-FX EMBOLIZATION PLUG IN ANATOMY THAT MAY LEAD TO UNINTENDED DEVICE PLACEMENT AND/OR MOVEMENT (I.E. HIGH FLOW VASCULATURE, LARGE LUMINAL VESSEL DIAMETER)." THE IMP-FX-12 PLUG REMAINS IN A FALSE LUMEN OF THE INFRARENAL AORTA. NO SERIOUS CLINICAL ADVERSE EVENT TO THE PATIENT WAS REPORTED. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE RECEIVED FROM THE COMPLAINANT. NOTE: THE IMPEDE-FX-US IFU1354-01 REV A ALSO STATES THAT "THE IMPEDE-FX EMBOLIZATION PLUG IS INDICATED FOR USE WITH THE IMPEDE EMBOLIZATION PLUG TO OBSTRUCT OR REDUCE THE RATE OF BLOOD FLOW IN THE PERIPHERAL VASCULATURE;" THIS MEANS THE IMPEDE-FX DEVICE IS INDICATED TO BE USED WITH THE IMPEDE DEVICE (510K NUMBER: K181051) TO MITIGATE MIGRATION RISKS. THE PATIENT WAS IMPLANTED WITH 2 IMP-FX-12 DEVICES AND A STENT. SHAPE MEMORY MEDICAL COMPLAINT REFERENCE NUMBER: (B)(4).
ON (B)(6) 2025 AT (B)(6) MEDICAL CENTER IN (B)(6) USA, DURING TREATMENT OF A TEVAR AND SMA STENT/EMBOLIZATION AN IMP-FX-12 PLUG MIGRATED AND WAS NOT DELIVERED AT THE TARGET SITE. THE IMP-FX-12 PLUG WAS PLANNED FOR EMBOLIZATION OF THE SMA DISSECTION AFTER A SELF-EXPANDING STENT WAS DEPLOYED IN THE SMA TRUE LUMEN. DURING DEPLOYMENT OF THE IMP-FX-12 PLUG, THE PLUG TRAVELED INTO THE INFRARENAL AORTA. IT IS UNKNOWN IF THE 5F SHEATH USED TO DELIVER WAS IN THE RIGHT LOCATION. DR. (B)(6) DECIDED TO LEAVE THE PLUG IN THE INFRARENAL AORTA AND CONTINUE WITH THE PROCEDURE AS A 2ND IMP-FX-12 PLUG WAS DEPLOYED AND IMPLANTED AT THE TARGET LOCATION - THE SMA DISSECTION. THE PHYSICIAN THEN STOPPED THE PROCEDURE AFTER THE FLUOROSCOPY STOPPED WORKING. ON (B)(6) 2025, IT WAS INITIALLY REPORTED BY THE SHAPE MEMORY MEDICAL (SMM) EMPLOYEE FAMILIAR WITH THE CASE THAT THE 1ST IMP-FX-12 PLUG TRAVELED INTO THE INFRARENAL AORTA. ON (B)(6) 2025, FROM A FOLLOW-UP EMAIL REGARDING THE CASE, IT WAS REPORTED BY ANOTHER SMM EMPLOYEE FAMILIAR WITH THE CASE THAT THE 1ST IMP-FX-12 TRAVELED TO THE FALSE LUMEN OF THE AORTA AND THE PHYSICIAN DID NOT FIND IT A CONCERN TO LEAVE THE IMP-FX-12 PLUG IN THIS LOCATION; THE IMP-FX-12 PLUG REMAINS IN A FALSE LUMEN OF THE INFRARENAL AORTA OF THE PATIENT. NO SERIOUS CLINICAL EVENT OCCURRED TO THE PATIENT AND THE PATIENT IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863993 | IMPEDE-FX EMBOLIZATION PLUG | VASCULAR EMBOLIZATION DEVICE | KRD | SHAPE MEMORY MEDICAL, INC. | IMP-FX-12 | 00810041650054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |