MAUDE Adverse Event Report: MERZ NORTH AMERICA RADIESSE DERMAL FILLER; INJECTABLE IMPLANT

Catalog Number 8071M0K1

Device Problem No Apparent Adverse Event (3189)

Patient Problem Stroke/CVA (1770)

Event Date 12/03/2015

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria of life-threatening.The lot number was not reported.

Event Description

A (b)(6) year old female consumer reported that she was treated with radiesse.Medical history and concomitant medications were not reported.On an unknown date in (b)(6) 2015, she was injected with one syringe of radiesse into her right hand.She reported that she had a stroke during the injection into her right hand and the provider called 911.Treatment and outcome were not reported.No further information is available.The consumer declined to provide contact information.

Manufacturer Narrative

The device history record for radiesse dermal filler lot#100084787 was reviewed.No non-conformances were discovered that would have contributed to this event.A lot search was conducted on the reported lot and no similar events were noted.

Event Description

Additional information was received from the physician injector on 11-may-2016.The physician reported that patient was injected with radiesse injectable implant to the right hand.Medical history reported as "patient has a hole in her heart." on (b)(6)-2015, patient was injected with less than one syringe of radiesse to the right hand.Patient had a right sided cva after injection, while doctor was massaging hand.Treatment not reported.Outcome reported as mostly recovered.Causality reported as could be related.Lot number reported as 100084787.On (b)(6)-2016, follow up information was received from the physician.Medical history positive for hypertension, high cholesterol, and a "hole in her heart".Concomitant medications reported as atorvastatin, triamterine hctz, montelucast, potassium, premarin, and vitamin d.Prior to injection, radiesse 1.5cc syringe was mixed with 0.3cc of 1% "plain" lidocaine.Patient had thin, fragile skin on her hands and, at time of injection, physician remembers nicking a blood vessel but is sure she did not inject into the vein.Post injection, physician was massaging patient's right hand and patient reported feeling faint.Patient's blood pressure was checked, with result of 159/84.Patient was placed in trendelenburg position and given 2l of oxygen via nasal cannula.Patient then reported heaviness in her left arm, back pain and numbness to the right side of face.Physician called the paramedics, who transported patient to hospital emergency room.Patient received a "full work-up", including ct scan, mri, and carotid ultrasound.Injecting physician spoke with emergency room physician, who confirmed patient had a stroke and stated patient was not a candidate for tpa.Patient was hospitalized, where she received physical therapy.Other treatment unknown.Patient was discharged from hospital on an unknown date.On an unknown date "recently", patient presented to injecting physician for follow-up and reported the tests she had while hospitalized were "clear." outcome reported as mostly recovered but with continued weakness in the left arm and left side of face.Causality reported as could be related.Physician cannot rule out relatedness.

Event Description

On 02-mar-2018, follow-up information was received from the physician: the patient was last seen by the physician in (b)(6) 2017.At that time, she still had weakness to her left arm and hand.The weakness in her face was "minimal".She also had balance issues but the physician was uncertain if this was related to the stroke.No additional treatment has been prescribed.The physician thinks the weakness of left hand and arm may be permanent.

• Brand Name: RADIESSE DERMAL FILLER
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA; 4133 courtney road; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: scott sykes, md ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 5510198
• MDR Text Key: 40656356
• Report Number: 2135225-2016-00004
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/25/2018
• Device Catalogue Number: 8071M0K1
• Device Lot Number: 100084787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided; 03/02/2018
• Supplement Dates FDA Received: 05/31/2016; 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR