MAUDE Adverse Event Report: INTEGRA - ACELL(COLUMBIA) UNKNOWN MICROMATRIX

Catalog Number XXX ¿ MICROMATRIX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); Embolism/Embolus (4438); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

The journal ophthalmic plast reconstr surg (2023): "multiple retinal emboli and medial canthal swelling following injection of acellular porcine urinary bladder matrix for hair restoration".Case report: "a 64-year-old female presented to the institution from an outside plastic surgery office with acute-onset od pain and blurred vision after subcutaneous injection of local anesthetic followed by dilute acellular porcine urinary bladder matrix to promote hair growth.Symptom onset occurred immediately following injection of acellular porcine urinary bladder matrix rather than local anesthetic.At presentation, visual acuity was 20/80 eccentrically in the od and 20/20 in the os, with a right relative afferent pupillary defect.Extraocular movements were full.Confrontational visual fields in the od were constricted inferiorly and temporally, and od color vision was reduced (6/10 ishihara plates).External examination at the outside plastic surgery office was significant for blanching of the skin along the supraorbital and supratrochlear arterial distributions on the right.Fundus examination of the od revealed multiple nonrefractile yellow emboli at retinal arteriolar branch points most prominent at the posterior pole, which was captured on ultra-widefield fundus imaging.Late phase fluorescein angiography demonstrated delayed arterial filling temporal to the macula extending peripherally that corresponded to areas distal to the emboli, with an area of persistent nonperfusion inferotemporally.Optical coherence tomography of the right optic nerve and macula appeared normal.The patient was admitted to inpatient neurology for stroke workup to rule out other contributory etiologies of cardioembolism.Hemoglobin a1c and low-density lipoproteins were slightly elevated at 7.2 and 111, respectively.Otherwise, erythrocyte sedimentation rate, c-reactive protein, electrocardiogram, transthoracic echocardiogram, mri and computed tomography angiography of the brain and orbits were normal.Two weeks later, external examination revealed new swelling of the right medial canthus without tearing, erythema or fluctuance, which was felt to possibly represent recruitment of vessels after proximal occlusion in the facial vasculature.Although the swelling did not appear consistent with dacryocystitis or cellulitis, she was conservatively treated with oral amoxicillin/clavulanate and trimethoprim/polymyxin b eyedrops.At 1-month follow up after initial presentation, visual acuity of the od had improved to 20/25 with resolution of the relative afferent pupillary defect.Confrontational visual fields remained constricted inferiorly but color vision was full (10/10 ishihara plates).External examination revealed marked improvement in right medial canthal swelling and fundus examination was normal with no visible emboli.".This report is to include: retinal emoboli, decreased visual acuity, and swelling of the right medial canthus ¿ treatment with oral amoxicillin/clavulanate and trimethoprim/polymyxin b eyedrops.Doi: 10.1097/iop.0000000000002383.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Micromatrix was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined; if additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received: "i saw this patient as the oculoplastic surgeon consulted for eyelid /medial canthal swelling (b)(6) 2021.She presented to our ed (b)(6) 2021 for the initial vision issue and had an extensive evaluation and workup by the retina surgeon and neurology team.She was admitted to the hospital, had systemic stroke workup including mra, had heparin, etc."."the injection was done elsewhere, by a plastic surgeon.She had had the injections previously.She noted the symptoms of blurry vision, pain and dizzyiness immediately after injection and was taken to the ed by ambulance.Blanching was noted in the supraorbital and supratrochlear region.My understanding is that the patient received lidocaine with epi and bupivacaine injection prior to the injection and the patient told me (granted this was several weeks after and from the patient, not the injector) that they were told it could¿ve been a reaction to the epinephrine."."i am not aware of the details of what was used to dilute the mm or the concentration."."the patient has a reported allergy to percocet causing nausea.No known porcine allergies."."she has high cholesterol."."i don¿t know about the legality of disclosing the name of the plastic surgeon to you for more details.If this is needed i can ask my hipaa officer.".

• Brand Name: UNKNOWN MICROMATRIX
• Type of Device: MICROMATRIX
• Manufacturer (Section D): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; 6640 eli whitney drive; columbia MD
• Manufacturer (Section G): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; columbia MD
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16806580
• MDR Text Key: 313918760
• Report Number: 3005920706-2023-00001
• Device Sequence Number: 1
• Product Code: KGN
• Combination Product (y/n): N
• PMA/PMN Number: K172399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX ¿ MICROMATRIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female