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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMATRIX / GENZYME CORPORATION SYNVISC (HYLAN G-F 20); ACID, HYALURONIC, INTRAARTICULAR

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BIOMATRIX / GENZYME CORPORATION SYNVISC (HYLAN G-F 20); ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Collapse (2416); Shaking/Tremors (2515)
Event Date 03/14/1998
Event Type  Death  
Event Description
My husband (b)(6) was released from (b)(6) hospital on (b)(6) 1998, after a stay for the treatment of fibrosis of the lungs.While en route home, he became sedentary and began shivering.As mr.(b)(6) entered his home, he collapsed on the floor and was taken to (b)(6) hospital where he died that afternoon in the emergency room.An autopsy was performed on his body by the hospital staff and a death certificate prepared reflecting a "myocardial infarction" as the cause of death.(see exhibit 1) however, autopsy findings do not provide support for that conclusion.The autopsy report reflects quote, ''no areas of total occlusion, approximately 70%, with no evidence of an acute thrombotic episode." ''the all blown histologic changes of an acute myocardial infarction were not evident''.(exhibit 2) my husband was admitted to (b)(6) hospital on (b)(6) 1998 for the treatment of fibrosis of the lungs.Before mr.(b)(6) release, a new treatment for mild arthritis of the knee joint called ''synvisc" was vigorously promoted by a relentless dr.(b)(6) (a physician appointed by referral) over and above all objections and concerns voiced by mr (b)(6) and his family.Before dr (b)(6) administered his "synvisc'' injections, my husband had told me that he had declined dr (b)(6) synvisc treatment offers because, at that time the effectiveness of synvisc was not well established (exhibit 3).On the evening of (b)(6) 1998, i was informed via telephone by a hospital staff nurse that dr.(b)(6) had scheduled my husband to receive a number of ''synvisc" injection that night.After hearing this, i immediately drove to (b)(6) hospital in an effort to prevent dr.(b)(6) from administering his injections.I arrived late in the evening, just after dr (b)(6) had administered a number of "lidocaine-synvisic" combination injections to my husband's knee joints.On (b)(6) 1998, dr.(b)(6) had administered at least 2 sets of 2 lidocaine-synvisc injections to my husbands knee joints before his release from the hospital that day (exhibit 4).This was done by dr.(b)(6) in total disregard for the pharmaceutical mfr's warning never to administer repeated synvisc injections to any patient until ''one full week'' had past since the last injection given to lessen the chances of allergic reactions or other- adverse events (exhibit 5).Additionally, dr.(b)(6) mixed all the synvisc injections given to (b)(6) with the anesthetic "lidocaine", an act specifically forbidden by the synvisc manufacturer (exhibit 6).The synvisc manufacturer warns physicians to never inject any patient with a synvisc - anesthetic mixture, as this can effect the safety and effectiveness of synvisc.(exhibit 7).Additionally, the synvisc manufacturer clearly warns physicians to never use synvisc on any patient with venous or lymphatic stasis present in the legs (swollen ankles), a condition (b)(6) hospital staff noted that (b)(6) was suffering from on the night dr.(b)(6) administered his injections.(exhibit 8) the fact that mr.(b)(6) collapsed upon arrival at home makes it clear that (b)(6) was not fit for release from (b)(6) medical center on that morning ((b)(6) 1998), and that dr.(b)(6) should not have released (b)(6) from hospital observation and care on the same day that he gave so many injections to mr.(b)(6) in a manner so contrary to manufacturer's warnings and directives.Upon (b)(6) arrival at (b)(6) hospital emergency room, the attendant physician, dr (b)(6), was shown information sent home with (b)(6) that day and made aware of the synvisc-lidocaine combo injections given to my husband prior to the onset of his collapse.(exhibit 9) without any consideration given to mr.(b)(6) then current lidocaine blood serum level, or any evaluation made of the possible toxic effects of that pre-existing level, at 1823 hours, dr.(b)(6) started a lidocaine drip into (b)(6) and from then onward, his blood pressure crashed along projected lines.At 1826 hours, mr.(b)(6) blood pressure fell to 95/67.At 1837 hours, his blood pressure fell to 66/47.At 1844 hours, the lidocaine drip was stopped.By 1849 hours, anesthetized cardiac paralysis was in full effect and three defibrillation attempts produced no results.At 1849 hours, the death code was called and dr.(b)(6) gave (b)(6) up for dead.(exhibit 10) the established lethal dose threshold for lidocaine is cited as anything above 15 micrograms per milliliter of serum.(exhibit 11) the analytical toxicology performed afterward on (b)(6) blood serum reflected a lidocaine concentration of 830 micrograms per milliliter (exhibit 12) which is exceedingly greater than the lethal dose threshold for that drug.When dr.(b)(6) injected additional lidocaine into (b)(6) system, he compounded the problem past the point of solution.(exhibit 13) (b)(6) was killed by a physician induced lidocaine overdose, the degree of that carelessness would cause any person to suffer the insurrection of death.This (b)(6) y/o man with a history of lung disease, died approx 2 hours after collapsing.The electrocardiogram and serum enzymes were indicative of an acute myocardial infarction.History: the pt was just discharged from (b)(6) and arrived home with wife on portable oxygen.He went into the house.Wife went back to the car to get some items, and when she returned to the house she found him unconscious on the floor with agonal respirations.The (b)(6) fire department was called and found him lying on the floor between a wall and a table, cpr in progress by family.The patient responsive, respiratory rate of 12, minimal carotid pulse palpable.Became pulseless and cpr as started and continued.Pulse initially 76 carotid, no blood pressure palpable.Respirations are 12.Skin arm and moist.Pupil dilated.Capillary refill more than three seconds.No obvious jugular venous distention seen.Breath sounds initially clear and equal bilaterally.Abdomen was ''round.'' no urine or stool incontinence was noted.With idioventricular rhythm and pea.The pt intubated by medics with equal breath sounds to bagging.Attempted ivs peripherally without success.Was given 1 mg of epinephrine and 1 mg of atropine through the et tube, and when this produced no response a second round as given.Right internal jugular was started by medics and dopamine was begun.The pt received approx 70 cc of fluid en route.Three more milligrams of epinephrine iv and 2 mg more of atropine although he had developed apparent bigeminal rhythm versus nsr with first degree av block.Wife and son stated that the pt had been just hospitalized for three months at (b)(6) hosp for pulmonary fibrosis, and has a history of non-insulin dependent diabetes for one year and hypertension.Also had intra-articular instillation of hyaluronate "for both knees" several days ago, and is followed by dr (b)(6) and dr (b)(6).
 
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Brand Name
SYNVISC (HYLAN G-F 20)
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOMATRIX / GENZYME CORPORATION
MDR Report Key10815998
MDR Text Key215985828
Report NumberMW5097731
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/08/2001
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age81 YR
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