HYDROFRAME 10 FRAMING COIL VTA
Report
- Report Number
- 2032493-2023-00829
- Event Type
- Injury
- Date Received
- July 7, 2023
- Date of Event
- June 28, 2023
- Report Date
- September 7, 2023
- Manufacturer
- MICROVENTION, INC
- Product Code
- HCG
- PMA / PMN Number
- K090357
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: ADDITIONAL INFORMATION PROVIDED. H10: ITEMS RETURNED FOR EVALUATION: PUSHER IMPLANT INTRODUCER MICROCATHETER ITEMS NOT RETURNED FOR EVALUATION: DISPENSER HOOP SHRINK LOCK V-GRIP PHYSICAL DEVICE REVIEW: DURING THE VISUAL ANALYSIS OF THE RETURNED ITEMS, IT WAS DISCOVERED THAT THE PUSHER WAS BROKEN AT THE TRANSITION AREA. SUBSEQUENTLY, A SECTION OF THE PUSHER WAS FOUND TO BE LODGED INSIDE THE RETURNED MICROCATHETER. UPON FURTHER INSPECTION, IT WAS OBSERVED THAT THE IMPLANT REMAINED ATTACHED TO THE PUSHER BUT WAS SEVERELY STRETCHED, BROKEN, AND STUCK IN THE MICROCATHETER. THE RETURNED FILAMENT WAS IDENTIFIED AS A PART OF THE BROKEN IMPLANT; HOWEVER, THE DISTAL PORTION OF THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE RETURNED MICROCATHETER WAS FOUND TO BE IN GOOD CONDITION WITH NO SIGNS OF DAMAGE OR KINKING. IMAGING REVIEW THREE RADIOGRAPHIC IMAGES AND A VIDEO ARE SUPPLIED. P23-3325 IMG_5817 KOPIE: CORONAL CT CENTERED OVER SKULL BASE AND DISTAL CERVICAL AREAL, NO CONTRAST. A ¿BUNCHED UP¿ COIL IS SEEN IN THE DISTAL CERVICAL ICA. A STRAIGHT SEGMENT OF THE COIL IS SEEN IN THE PETROUS ICA. A COIL BALL IS SEEN IN THE RIGHT PCOM ANEURYSM THAT IS SEEN ON A LATER DSA IMAGE (P23-3325 IMG_5818 KOPIE). P23-3325 IMG_5818 KOPIE: RIGHT ICA DSA, LATERAL, SUBTRACTED, WITH CONTRAST, CENTERED OVER CERVICAL AREA AND SKULL BASE. A LOOSE COIL BALL IS SEEN IN A SMALL (ABOUT 3 X 4 MM) PCOM ANEURYSM. THE COIL EXTENDS OUT OF THE ANEURYSM IN A LINEAR CONFIGURATION ALL THE WAY DOWN TO THE LOW CERVICAL ICA, WHERE IT IS ¿BUNCHED UP¿. SOME STENT MARKERS (3) ARE SEEN IN THE PETROUS ICA (AS SUBTRACTION ARTIFACTS). IF THERE ARE MORE STENT MARKERS, THEY ARE NOT SEEN, AS THEY WOULD BE SUBTRACTED. P23-3325 IMG_5819 KOPIE: SAME AS P23-3325 IMG_5818 KOPIE. THE CAUSE FOR THE COMPLAINT IS NOT SEEN ON THESE IMAGES. P23-3325 IMG_5816.MOV: THIS MOVIE WAS REFORMATTED AND IT IS A ¿FLY-THROUGH¿ OF THE CORONAL CT CENTERED OVER THE SKULL BASE AND DISTAL CERVICAL AREAL, NO CONTRAST (P23-3325 IMG_5817 KOPIE), AND ADDS NOTHING TO WHAT IS NOTED PREVIOUSLY. THREE IMAGES AND A VIDEO WERE PROVIDED BY THE CUSTOMER FOR REVIEW. IN THE PROVIDED IMAGING, A ¿BUNCHED UP¿ COIL IS SEEN IN THE DISTAL CERVICAL ICA, A STRAIGHT SEGMENT OF THE COIL IS SEEN IN THE PETROUS ICA, AND A LOOSE COIL BALL IS SEEN IN A SMALL (ABOUT 3 X 4 MM) PCOM ANEURYSM. THE COIL EXTENDS OUT OF THE ANEURYSM IN A LINEAR CONFIGURATION ALL THE WAY DOWN TO THE LOW CERVICAL ICA, WHERE IT IS ¿BUNCHED UP¿. THE CAUSE OF THE REPORTED COMPLAINT WAS NOT OBSERVED IN THE PROVIDED MEDICAL IMAGING. HOWEVER, THE INVESTIGATION OF THE RETURNED DEVICE REVEALED ISSUES WITH THE PUSHER, AS IT WAS FOUND TO BE BROKEN AT THE PROXIMAL SECTION, AND ITS DISTAL SECTION WAS LODGED INSIDE THE MICROCATHETER. FURTHER INVESTIGATION FOUND THE IMPLANT STILL ATTACHED TO THE PUSHER, STRETCHED, BROKEN, AND STUCK WITHIN THE MICROCATHETER. THE BROKEN CONDITION OF THE PUSHER IS CONSISTENT WITH THE DEVICE EXPERIENCING EXCESSIVE FORCE THAT EXCEEDED THE DEVICE'S TENSILE STRENGTH, RESULTING IN THE PUSHER BREAKING. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE MICROCATHETER USED IN THE PROCEDURE WAS ALSO EVALUATED AND FOUND TO BE IN GOOD CONDITION WITH NO SIGNS OF DAMAGE OR KINKING.
THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. THE PREMATURE SEPARATION AS DESCRIBED COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED¿WITH THE USE OF THE DEVICE.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT AS OF LATE JUNE PATIENT STATUS WAS "OK" . THE "MORE STRETCHED FILAMENTS WERE BUNDLED" WAS CLARIFIED TO MEAN NO OTHER MICROVENTION COILS STRETCHED, THE FILAMENTS WERE FROM THE COMPLAINED COIL, ONLY ONE COIL WAS USED . PLEASE ALSO SEE H6 AND H10.
IT WAS REPORTED THAT DURING AN ICA ANEURYSM, BALLOON ASSISTED COILING PROCEDURE WAS PERFORMED. THE COMPLAINED COIL WAS THE FIRST COIL AND COULD NOT BE PLACED COMPLETELY IN THE ANEURYSM SAC. THE PHYSICIAN DECIDED TO RESHEATH THE COIL. DURING RESHEATHING PROCESS, THE COIL STRETCHED AND TORE OFF. AS BAIL OUT, THE STENT RETRIEVERS AND ASPIRATION CATHETER WERE USED TO CATCH THE COIL. PHYSICIAN DECIDED TO DEPLOY A STENT OVER THE ANEURYSM TO SECURE THE COIL WIRE AT THE VESSEL WALL. MORE STRETCHED FILAMENTS WERE BUNDLED IN THE PROXIMAL ICA, WHICH WERE PROTECTED WITH TWO MORE STENTS. IT IS NOTED ONLY THE STRETCHED DELIVERY PUSHER IS AVAILABLE FOR EVALUATION AS THE COIL REMAINS IMPLANTED. THE PATIENT WAS AWAKE AFTER THE PROCEDURE, NO OTHER DETAILS CURRENTLY KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498333 | HYDROFRAME 10 FRAMING COIL VTA | NEUROVASCULAR EMBOLIZATION COIL | HCG | MICROVENTION, INC | 100410HFRM-V-A2 | 2106155PF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | SOFIA 5F (ASPIRATION CATHETER)| STENT (ACCLINO FLEX, ACANDIS)| STENTRETRIEVERS (PRESTE 6X50 - EMBOTRAP) |