MAUDE Adverse Event Report: MERZ NORTH AMERICA INC. RADIESSE VOICE; INJECTABLE IMPLANT

Catalog Number 8044M0

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Erythema (1840); Fatigue (1849); Itching Sensation (1943); Paresis (1998); Tachycardia (2095); Dysphasia (2195); Urticaria (2278); Malaise (2359); Reaction (2414); No Code Available (3191)

Event Type  Other  

Event Description

A (b)(6) male with no known food or airborne allergies underwent esophagotomy with mediastinal lymph node dissection for squamous cell carcinoma.Post operatively, he complained of hoarseness, decreased vocal projection, cough, and dysphagia and was found to have a left vocal cord paresis.Seventeen days after surgery, he underwent uncomplicated injection augmentation in the office under topical and local anesthesis, using a total of 0.5cc of carboxymethylcellulose.One year later, his paresis had progressed to a frank paralysis due to recurrent carcinoma in the mediastinum.His voice was again breathy and his cough had returned.Given his overall prognosis, repeat injection augmentation with a longer-lasting material was recommended.Prior to the procedure, the patient took 5mg of zolpidem for relaxation.A 1cc of 1% lidocaine with epinephrine 1:100,000 was injected subcutaneously near the cricothyroid space.Additionally, pledgets with topical 2% lidocaine and phenylephrine were placed in the nose.After several minutes, augmentation was performed percutaneously under flexible laryngoscopic control without difficulty.A total of 0.7cc pf caha was used.He tolerated the procedure well and was discharged after 20 minutes of observation.Ten minutes later, he developed diffuse, severe itchiness and his wife noticed hives on his chest.She immediately returned him to the office.He denied respiratory difficulty but complained of a sudden feeling of fatigue and malaise.Additionally, while he had no respiratory noise, his voice had become low-pitched and rough.Examination revealed mild tachycardia with normal blood pressure, diffuse urticaria and marked facial erythema and edema.His eyelids had swollen shut.An allergy specialist within the same department was immediately consulted and a diagnosis of anaphylaxis was made.After placing the patient in a recumbent position, 0.3mg of epinephrine (1:1000) was given intramuscularly in addition to supplemental oxygen.His vital signs remained stable and his urticaria started to improve.He was transferred to the emergency department, where he received intravenous hydration, diphenhydramine, dexamethasone and continued observation for late-phase reaction.His symptoms resolved after 6 hours and he was discharged with no further complications.Follow up examination 2 weeks later showed no sign of residual edema with adequate airway.Glotic insufficiency was well-addressed by the injection.The lot number of the radiesse voice was not provided in the article.

Manufacturer Narrative

The laryngoscope 123: 2237-2239, 2013.September 2013 cohen et al: severe systemic reaction from calcium hydroxylapatite vocal fold filler.Justin c cohen, md, william reisacher, md, melanie malone, md, lucian sulica, md.

• Brand Name: RADIESSE VOICE
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA INC.; franksville WI
• Manufacturer Contact: ann metz ; 4133 courtney road; suite 10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 3690791
• MDR Text Key: 4289615
• Report Number: 2135225-2014-00017
• Device Sequence Number: 1
• Product Code: KHJ
• Combination Product (y/n): N
• PMA/PMN Number: K013243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8044M0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PHENYLEPHRINE IN THE NOSE; PLEGLETS WITH TOPICAL 2% LIDOCAINE AND; 1CC OF 1% LIDOCAINE WITH EPINEPHRINE 1:100,000 WAS; INJECTED SUBCUTANEOUSLY NEAR THE CRICOTHYROID; SPACE
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR