V-STEADY
Report
- Report Number
- 3010899956-2024-00001
- Event Type
- Injury
- Date Received
- May 15, 2024
- Date of Event
- August 25, 2021
- Report Date
- May 8, 2024
- Manufacturer
- G21 S.R.L.
- Product Code
- NDN
- UDI-DI
- 08058964723819
- PMA / PMN Number
- K150408
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2021 (B)(6) UNDERWENT TO FLUOROSCOPY GUIDED KYPHOPLASTY AT T3/T4 AT FREEWAY SURGICAL CENTER BY DR. (B)(6) USING V-STEADY BONE CEMENT. ON (B)(6) 2021 A CT WITH CONTRAST SHOWED EXTRAVASATION OF METHYL METHACRYLATE. DR. (B)(6) CALLED MS. (B)(6) AND TOLD HER "THERE IS EVIDENCE THAT CEMENT IS PROPAGATING FROM THE T7 VERTEBRAL BODY INTO A PERIVERTEBRAL DRAINING VEIN AND INTO/AROUND/NEAR THE HEART." NO NOTIFICATION OF ADVERSE EVENT HAS BEEN RECEIVED AT THAT TIME, NOR HAS BEEN FOUND DURING POST MARKET SURVEILLANCE ACTIVITIES CARRIED OUT ON MAY 09, 2022 RELATED TO DATA OF YEAR 2021, PERFORMED ON (B)(6) 2023 RELATED TO DATA OF YEAR 2022 AND PERFORMED ON (B)(6) 2024 RELATED TO DATA OF YEAR 2023. IN PARTICULAR, A REVIEW OF GOVERNMENT WEBSITES WAS CONDUCTED TO LOOK FOR DEVICE FAILURES REPORTED BY COMPETITORS AND G21 ON A SYSTEMIC BASIS. THIS IS USEFUL IN IDENTIFYING UNKNOWN RISKS; PROBLEMS IDENTIFIED THROUGH THIS SURVEILLANCE SERVE AS INPUT TO THE RISK MANAGEMENT PROCESS, WHICH CAN TRIGGER APPROPRIATE DESIGN CONTROL ACTIVITY. FOLLOWING THE LIST OF WEBSITES USED: · FDA'S MAUDE DATABASE SYSTEM. · FDA 522 POSTMARKET SURVEILLANCE STUDIES. · FDA MEDICAL DEVICE RECALL. · MHRA. · AVVISI DI SICUREZZA. · CLINICALTIAL.GOV. · ANSM - AGENCE NATIONALE DE SÉCURITÉ DU MEDICAMENT ET DES PRODUITS DE SANTÉ. · BFARM - FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES. FIELD CORRECTIVE ACTIONS. A REVIEW OF BATCH RECORD WAS PERFORMED. IN MARCH 2021, (B)(4) UNITS OF INVOLVED PRODUCT WERE MANUFACTURED. 1 UNITS WAS KEPT BY THE MANUFACTURER AS COUNTER SAMPLE AND (B)(4) UNITS HAS BEEN SOLD TO SURGITECH LLC (INVOICE N°243 DATED 03/05/2021). NO NONCONFORMITIES HAVE BEEN FOUND. ALL THE UNITS MANUFACTURED HAVE BEEN SOLD TO SURGITECH LLC. A REVIEW OF COMPLAINT WAS PERFORMED AND ONE CASE IN WHICH THE CEMENT WAS EMBOLIZED INTO THE LUMBAR VEINS, INFERIOR VENA CAVA AND UPPER RIGHT LUNG. THE PRODUCT INVOLVED IS V-STEADY BATCH 20180300004 AND IT IS NOT THE SAME AS THE ONE INVOLVED IN THE PRESENT COMPLAINT. THIS EVENT WAS NOTIFIED ON AUGUST 25, 2020 BY CUSTOMER AND AUGUST 26, 2020 BY MHRA (UK MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY), THE EVENT OCCURRED IN AUGUST 17, 2020. THE EVENT OCCURRED IN CEMENT AUGMENTATION OF PEDICLE SCREWS PROCEDURE AND VERTICALE MIS WAS USED TO STABILIZE A L1 FRACTURE. G21 CEMENT WAS USED TO AUGMENT THE SCREWS AND PERFORM A VERTEBROPLASTY AT THE FRACTURE SITE." A FDA FORM 3500A HAS BEEN ISSUED (SEE MFR REPORT: # 3010898856-2020-00001). G21'S V-STEADY WAS CLEARED IN 2015 BY THE FDA FOR THE INTENDED USE/INDICATION FOR USE VERTEBROPLASTY/KYPHOPLASTY. THE LABELING CLEARED IN THE 510(K) CLEARLY IDENTIFIES THE POTENTIAL FOR CEMENT TO MIGRATE AWAY FROM THE SPINE AND INTO THE VASCULAR SYSTEM. THE LABELING ALSO CONTAINS WARNINGS OF COMPLICATIONS ARISING FROM THIS MIGRATION, INCLUDING PULMONARY EMBOLISM (WHICH THE PATIENT EXPERIENCED). THE CLINICIAN IS FURTHER WARNED THAT A PATIENT MAY DIE AS A RESULT OF THIS. THE USE OF BONE CEMENTS FOR VERTEBROPLASTY/KYPHOPLASTY WAS FIRST BEING USED BY CLINICIANS OFF LABEL IN EARLY 2000. FDA ISSUED A WARNING COMMUNICATION IN 2002 TO CLINICIANS ABOUT THE RISKS WITH USE OF CEMENTS IN THESE PROCEDURES INCLUDING PULMONARY EMBOLISM (AS EXPERIENCED BY THIS PATIENT) AND DEATH (NOTICE IS NO LONGER AVAILABLE ON THE FDA WEBSITE, HOWEVER, PLENTY OF ANNOUNCEMENTS ON THE WEB THAT CAN BE RETRIEVED). IN THE YEARS THAT FOLLOWED, MANY COMPANIES GAINED COMMERCIAL CLEARANCE IN THE US VIA 510(K) FOR THEIR CEMENTS AND THIS USE. FDA REQUIRED LABELING THAT WARNED THE READER (CLINICIAN) ABOUT THESE COMPLICATIONS AND OUTCOMES. G21 HAS ALL THE REQUIRED LABELED WARNINGS REGARDING THIS IN THEIR LABELING SINCE THEIR CLEARANCE IN 2015. THE PATIENT FROM (B)(6) THAT EXPERIENCED THIS UNFORTUNATE EVENT, DID NOT EXPERIENCE ANYTHING THAT WAS NOT WARNED AGAINST IN LABELING THAT FDA REVIEWED AND CLEARED. G21 CEMENT (LIKE ALL OTHER CEMENTS ON THE MARKET) MAY HAVE THE POSSIBILITY OF BREAKING OFF AND MIGRATING TO THE HEART/LUNG. HOWEVER, THE FDA CONCLUDED THAT THE BENEFIT OF USING CEMENT FOR THIS USE FAR OUTWEIGH THE RISKS. THEREFORE, THERE IS NO DESIGN DEFECT, THE SURGEON WAS WARNED, THE SURGEON SHOULD HAVE INFORMED THE PATIENT OF THESE POSSIBLE OUTCOMES AND G21 HAS NO LIABILITY IN THIS UNFORTUNATE SITUATION. CONCLUSION: WHEN THE EVENT OCCURRED IN SEPTEMBER 2021, THE MANUFACTURER G21 WAS NOT NOTIFIED. G21 ONLY BECAME AWARE OF THE EVENT FOLLOWING A REQUEST MADE BY THE PATIENT THROUGH HER LAW FIRM THROUGH FORMAL NOTICE AND SETTLEMENT DEMAND FOR PRODUCT LIABILITY CLAIMS OF (B)(6) ARISING FROM PERSONAL INJURIES SHE SUSTAINED ON (B)(6) 2021 AS A RESULT OF THE FAILURE OF DEFECTIVE V-STEADY BONE CEMENT AND THE RELATED DEVICES MANUFACTURED BY YOUR COMPANY FOR APPLICATION OF THE CEMENT CAUSING HER HEART AND LUNG EMBOLI WHICH REQUIRED OPEN HEART SURGERY HAS LEFT HER WITH PERMANENT INJURIES. REVIEW OF BATCH RECORD HAS BEEN PERFORMED AND NO NONCONFORMITIES HAS BEEN FOUND.
ON (B)(6) 2021 FLUOROSCOPY GUIDED KYPHOPLASTY AT THE T3/T4 USING V-STEADY BONE CEMENT TO STABILIZE VERTEBRAL BODIES OCCURRED ON PATIENT. SURGEON STATES "RADIOGRAPHS WERE OBTAINED THAT SHOWED GOOD FILLING WITH NO POSTERIOR EXTRAVASATION INTO THE SPINAL CANAL" AND "FINAL RADIOGRAPHS WERE OBTAINED THAT DEMONSTRATED APPROPRIATE FILLING PATTERNS." THE FOLLOWING DAY THE PATIENT RETURNED TO THE ER WITH PAINFUL BREATHING UPON INHALATION, AND EXPERIENCED PAIN IN HER THORACIC AREA WITH COUGHING, ANY MOVEMENT, AND BREATHING. PATIENT'S COMPLICATIONS PERSISTED AND ON (B)(6) 2021 A CT WITH CONTRAST SHOWED EXTRAVASATION OF METHYL METHACRYLATE SHOWING EVIDENCE THAT CEMENT WAS PROPAGATING FROM THE T7 VERTEBRAL BODY INTO A PERIVERTEBRAL DRAINING VEIN AND INTO/AROUND/NEAR THE HEART. AN ECHO (TTE X 4) WAS PERFORMED WHICH CONFIRMED THAT THERE WAS CEMENT IN THE VEINS TO PATIENT'S HEART. PHYSICIAN STATED THE CEMENT LEAKED INTO THE AZYGOS VEIN INTO THE MAIN ATRIUM IN THE HEART. THE CT SCAN REVEALED: "1. LONG LINEAR HYPERDENSE MATERIAL EXTENDING FROM THE T3 AND AND T4 VERTEBRAL BODIES (STATUS POST CEMENT AUGMENTATION), THROUGH THE RIGHT AZYGOS, RIGHT ATRIUM, AND RIGHT VENTRICLE. THIS IS FAVORED TO ALL REPRESENT EMBOLIZED METHYL METHACRYLATE FROM PRIOR CEMENT AUGMENTATION PROCEDURE. RECOMMEND CONSULTATION WITH INTERVENTIONAL RADIOLOGY OR CARDIOLOGY. 2. SMALL AREAS OF EMBOLIZED METHYL METHACRYLATE MATERIAL IN THE RIGHT LOWER LOBE AND LEFT LOWER LOBE.", CHEST XRAY ON (B)(6) 2021 REVEALED, "VERTEBROPLASTY CHANGES ARE PRESENT AT T4 AND T5. THERE IS EXTRUSION OF CEMENT INTO THE VENOUS SYSTEM INCLUDING INTO THE SUPERIOR VENA CAVA AND RIGHT HEART." ON (B)(6) 2021 PATIENT UNDERWENT STERNOTOMY SURGERY FOR THE REMOVAL OF CEMENT FROM THE PATIENT'S RIGHT ATRIUM. ON (B)(6) 2022 PATIENT'S PULMONOLOGIST STATED, "THIS IS A CHRONIC PROBLEM. THE PROBLEM'S PRECIPITANTES INCLUDE EXERCISE. ASSOCIATED MEDICAL ISSUES INCLUDE PE [PULMONARY EMBOLISM]" PULMONARY FUNCTION TESTS WERE UNREMARKABLE AND PATIENT RECEIVED AN RX FOR AN ALBUTEROL INHALER WITH A PLAN TO DISCUSS RADIOLOGY WITH CV SURGERY AND ORDER CT PROTOCOL. ON (B)(6) 2022 PULMONOLOGIST ASSESSMENT/PLAN STATED, "DISCUSSED WITH PATIENT AND WITH INTERVENTIONAL RADIOLOGY GIVEN THE SIZE LOCATION AND CONSISTENCY OF THE CEMENT IN THE LUNGS AND HER NORMAL PFTS INTERVENTIONAL RADIOLOGY FELT THAT RETRIEVAL OF THE CEMENT WILL BE DIFFICULT LIKELY UNSUCCESSFUL AND WILL NOT YIELD A MEANINGFUL IMPROVEMENT IN PATIENT'S SYMPTOMS, THEY ALSO FELT THE SAME WAY ABOUT THE CEMENT IN PATIENT'S AZYGOUS VEIN AND SUPERIOR VENA CAVA. PATIENT WAS GIVEN THE OPTION TO TALK WITH IVR IN THEIR CLINIC AND PATIENT WAS GIVEN OPTION TO DISCUSSING CARE WITH PATIENT'S ORIGINAL SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489957 | V-STEADY | CEMENT, BONE, VERTEBROPLASTY | NDN | G21 S.R.L. | 20210200118 | 08058964723819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Life Threatening| H| S |