Description of Event or Problem · 0
PASSED AWAY. MID THORACIC COLLAPSE/SPINAL DECOMPRESSION INCLUDING COLLAPSED T6. ACUTE DISABLING INTRASCAPULAR PAIN RADIATING THROUGH HIS CHEST TO HIS STERNUM. COPD. CAD [CORONARY ARTERY DISEASE]. CHEST PAIN. SOB [SHORTNESS OF BREATH]. ACUTE DISABLING INTRASCAPULAR PAIN RADIATING THROUGH HIS CHEST TO HIS STERNUM. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 12-JAN-2022 REGARDING A SOLICITED VALID SERIOUS CASE FROM PATIENT'S FAMILY MEMBER, IN THE SCOPE OF POST-MARKETING SPONSORED STUDY "(B)(6)". PATIENT ID: (B)(6); COUNTRY: (B)(6). STUDY TITLE: PATIENT SUPPORT PROGRAM INVOLVING SYNVISC ONE. THIS CASE INVOLVES A (B)(6) YEARS OLD MALE PATIENT WHO HAD MID THORACIC COLLAPSE/SPINAL DECOMPRESSION INCLUDING COLLAPSED T6, ACUTE DISABLING INTRASCAPULAR PAIN RADIATING THROUGH HIS CHEST TO HIS STERNUM, COPD, CAD, CHEST PAIN, SOB AND PASSED AWAY, AFTER THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC ONE]. THE PATIENT'S PAST VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. THE PATIENT HAD MULTIPLE MEDICAL AND ORTHOPEDIC COMORBIDITIES. THE PATIENT WAS RETIRED SOME 40 YEARS AGO WITH MULTIPLICITY OF MEDICAL AND SURGICAL PROBLEMS, RETURNED FOR REVIEW OF BILATERAL SHOULDER TENDINOPATHY PROVOKED BY CONSTANT USE OF FOREARM CANE SYMPTOMS FOR THE PAST 30 YEARS, SECONDARY ATAXIC GAIT PATTERN-ALL DATING BACK TO LOWER SPINE INJURIES SUSTAINED WHEN HE WAS EJECTED OUT OF HIS T-33 JET TRAINER IN MANITOBA 1968-I.E. USE OF FOREARM CANES THAT CONVERTED HIS SHOULDERS INTO WEIGHT BEARING JOINTS-I.E. CARE OF SUCH SHOULD BE COVERED BY DVA. REQUIRED AT LEAST 3 MAJOR LUMBAR SPINE PROCEDURES INCLUDING DECOMPRESSION/ INSTRUMENTATION/ FUSION TO 1969, REVISION INSTRUMENTATION AND FUSION L3-4 (B)(6) 1984 AND MYSELF USING CCD [COMPACT COTREL DUBOUSSET INSTRUMENTATION] WITH BONE GRAFT LEFT POSTERIOR ILIAC CREST. PROTRACTED RECOVERY WEANED OFF NARCOTICS BY (B)(6) 1994, BUT SECONDARY ATAXIC TYPE GAIT USING FOREARM CANES. THE PATIENT HAD CONCURRENT OA (OSTEOARTHRITIS) KNEES-ORIGINALLY INJURED TRYING TO MOVE 300 POUNDS CART AT WORK IN THE NAVY-6 OPEN ORS, 3 SCOPES FOR MEDIAL AND LATERAL MENISCECTOMIES/PATELLECTOMY RIGHT KNEE, EVENTUAL RIGHT TKR (TOTAL KNEE REPLACEMENT) BY (B)(6) 2006-RIGHT KNEE ALWAYS WEAK/A BIT SORE. COMPENSATORY LEFT KNEE OA, REQUIRING SCOPE AND DEBRIDEMENT (B)(6) 2012 FOR ADVANCED/BARE BONE GRADE 3 CMP/LARGE AND SMALL LOOSE BODIES/EXTENSIVE MEDIAL OA FRAGMENTATION/INTACT MENISCI/SATISFACTORY STABLE 15-130. POSTOP GOOD BUT WITH DIMINISHING EFFECT FROM "GREASE JOBS", REQUIRING EVENTUAL LEFT TKR IN 2015. ON (B)(6) 2014, THE PATIENT RECEIVED HYLAN G-F 20, SODIUM HYALURONATE INJECTION LIQUID (SOLUTION) (STRENGTH: 48 MG/ 6 ML) AT A DOSE OF 6 ML ONCE (LOT - S1302) FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE IN 2015, AFTER LATENCY OF FEW MONTHS, THE PATIENT PRESENTED WITH ACUTE DISABLING INTRASCAPULAR PAIN (MUSCULOSKELETAL PAIN) RADIATING THROUGH HIS CHEST TO HIS STERNUM (PAIN), CHEST PAIN, WITH ASSOCIATED SHORTNESS OF BREATH (DYSPNOEA) -FOUND TO HAVE SIGNIFICANT COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) /CAD (CORONARY ARTERY DISEASE) WITH SPINAL DECOMPRESSION INCLUDING COLLAPSED T6 (SPINAL CORD COMPRESSION, MEDICALLY SIGNIFICANT) FOR WHICH HE UNDERWENT REVISION DECOMPRESSION INSTRUMENTATION AND FUSION TO T8 ON (B)(6) 2015, WHICH REQUIRED REVISION INSTRUMENTATION AND FUSION 2 YEARS LATER. ON AN UNKNOWN DATE THE PATIENT PASSED AWAY (DEATH) (UNKNOWN LATENCY) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO DEATH. NO AUTOPSY WAS DONE. ACTION TAKEN: NOT APPLICABLE FOR ALL THE EVENTS. CORRECTIVE TREATMENT: UNDERWENT REVISION DECOMPRESSION INSTRUMENTATION AND FUSION TO T8 FOR MID THORACIC COLLAPSE/SPINAL DECOMPRESSION INCLUDING COLLAPSED T6, NOT REPORTED FOR REST ALL EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS FATAL FOR THE EVENT PASSED AWAY; UNKNOWN FOR REST ALL EVENTS. PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4) ON (B)(6) 2022 FOR PRODUCT SYNVISC ONE. BATCH NUMBER: S1302. SAMPLE STATUS: NOT AVAILABLE. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT S1302, EXPIRATION DATE APR-2016 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NONCONFORMANCES WERE NOTED. BASED ON THE LOT BATCH RECORD REVIEW & LOT FREQUENCY ANALYSIS FOR LOT S1302 NO CAPA (CORRECTIVE AND PREVENTIVE ACTION) IS REQUIRED. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSES POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. AS OF 07FEB2022 THERE ARE 30 COMPLAINTS ON FILE FOR LOT# S1302 AND ALL RELATED SUB-LOTS. 28 COMPLAINTS ARE ON FILE FOR LOT# S1302: (1) TIP BREAKAGE, (1) EXTRUSION ISSUE, (1) BARREL BREAKAGE AND (25) ADVERSE EVENTS. 2 COMPLAINTS ARE ON FILE FOR LOT# S13021: (1) EXTRUSION ISSUE AND (1) TIP BREAKAGE. SANOFI WOULD CONTINUE TO MONITOR COMPLAINTS AS STATED IN SOP (B)(4) PRODUCT EVENT HANDLING TO DETERMINE IF A CAPA (CORRECTIVE AND PREVENTIVE ACTION) WAS REQUIRED. FINAL INVESTIGATION COMPLETE DATE: 08-FEB-2022 WITH SUMMARY CODE NO ASSESSMENT POSSIBLE. REPORTER CAUSALITY: NOT REPORTED. COMPANY CAUSALITY: NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 08-FEB-2022. GLOBAL PTC RESULT, FORM AND STRENGTH ADDED. TEXT AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAR-2022 FROM OTHER HEALTHCARE PROFESSIONAL. CASE BECAME VALID AND MEDICALLY CONFIRMED. EVENTS ADDED- MID THORACIC COLLAPSE/SPINAL DECOMPRESSION INCLUDING COLLAPSED T6, ACUTE DISABLING INTRASCAPULAR PAIN RADIATING THROUGH HIS CHEST TO HIS STERNUM, COPD, CAD, CHEST PAIN, SOB. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY.