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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC DURAPATITE IMPLANT, DERMAL, FOR AESTHETIC USE

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MERZ NORTH AMERICA, INC DURAPATITE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular occlusion (vascular occlusion) was deemed to meet serious criteria of required intervention to preclude permanent impairment of a body function or permanent damage to a body structure. The device history record could not be reviewed as the lot number was not reported. Literature citation: williams, m. , burgess, c. , (2021). Management of calcium hydroxyapatite vascular occlusion in a hemophiliac with hiv-associated facial lipoatrophy, 1173-1174 doi: 10. 1097/dss. 0000000000002991.
 
Event Description
This case was linked to lssmv case number (b)(4), referring to the same literature article. This literature report from the united states of america concerns a (b)(6) male patient. He was injected with calcium hydroxyapatite, into the buccal fat pad (off label use of device). He had more than 10 treatments of calcium hydroxyapatite and poly-l-lactic acid dermal filler over the course of 20 years. Treatments were administered by his dermatologist and routinely preceded by infusion of clotting factor viii, as recommended by his hematologist. Standard precautions were followed to include the use of a 0. 50 x 38 mm (25-gauge 1. 5 inch) cannula, fanning technique, deposition of small aliquots of 0. 2 ml or less, and aspiration of sites before injection. The patients medical history included hemophilia a and hiv-associated facial lipoatrophy. The patient had a history of minor post procedure bruising. Within 24 hours after the calcium hydroxyapatite injection, the patient experienced bruising and persistent dull aching pain in his right cheek but did not report the symptoms to the dermatologist for 1 week, given his previous history of minor post procedure bruising. One week after the calcium hydroxyapatite injection, the patient presented with pain, crusting, and purpura in the infraorbital area of his right cheek. On examination, he was noted to have a crusted erythematous plaque associated with reticulated nonblanching erythema, and an injected right sclera. The patients vital signs, snellen visual acuity, confrontational visual fields, and ocular motility were within normal limits. Dermatologic findings were consistent with dermal filler-associated vascular occlusion and vascular compromise of vessels in the right infraorbital area. Although available recommendations for vascular occlusion included antiplatelet or anticoagulant therapy, the patient was not eligible for anticoagulants given his history of type a haemophilia. The patient was treated with 2 ml of normal saline (0. 9% ns) irrigation to the injection site and began a regimen of 2% nitroglycerin paste once daily along with twice weekly 660 nanometer red light to prevent scaring and necrosis. He received a total of 8, 2-minute 660 nanometer red light sessions twice per week for 1 month and continued topical nitroglycerin paste once daily for a total of 8 weeks. Serial clinical evaluation demonstrated marked improvement with gradual restoration of skin integrity, and resolution of crusted plaques, and minimization of erythema and purpura. There was considerable resolution of the vascular lesion at 8 weeks post procedure with decreased facial sensitivity, and complete resolution without cutaneous scarring at week 24. The right cheek was without signs of cutaneous scarring or necrosis, and there was a complete resolution of the vascular lesion. Due to the provided information, the outcome of the event was considered as resolved. In the opinion of the authors, impaired hemostasis and diminishing coagulability after factor viii injection likely contributed to the lack of symptom escalation within the first week. Repeated injection to the buccal fat pad over the patients 20-year course likely resulted in residual volume and collagen stimulation that contributed to vessel compression. Although the fluence and low dose 660-nm light had an unknown contribution to the final outcome, it was the authors opinion that it helped. Updated recommendations for the management of calcium hydroxyapatite vascular occlusion included hyaluronidase flooding of the surrounding skin to reduce edema and inflammation, aspirin for clot and platelet aggregation prevention, smooth muscle relaxing drugs for blood vessel dilation and increased blood flow, subcutaneous low molecular weight heparin for thrombus and embolus prevention, topical nitroglycerin for vasodilation and tissue necrosis prevention, oral corticosteroid taper for edema reduction, as well as prophylactic antivirals in patients with histories of oral herpes simplex or nasalmucosal involvement. There was no available guidance for the management of calcium hydroxyapatite filler-induced vascular occlusion in patients in whom anticoagulation was contraindicated or those with clotting deficiencies.
 
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Brand NameDURAPATITE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
MERZ NORTH AMERICA, INC
4133 courtney street
suite 10
franksville WI 53126
Manufacturer (Section G)
MERZ NORTH AMERICA, INC
4133 courtney street
suite 10
franksville WI 53126
Manufacturer Contact
product safety
6501 six forks rd
raleigh, NC 27615
9195828000
MDR Report Key13284584
MDR Text Key289279562
Report Number3013840437-2022-00006
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
Treatment
FACTOR VIII ANTIHAEMOPHILIC FACTOR) (INFUSION)
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