MAUDE Adverse Event Report: GALDERMA Q-MED AB SOLESTA; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Lot Number UNKNOWN

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

Patient Problems Cyst(s) (1800); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The lot number was not reported and could not verify the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Company comment: the serious event of implant site cyst and the non-serious event of device dislocation were considered expected and possibly related to the treatment.Seriousness criteria include the need for surgical intervention to prevent permanent damage.The potential root cause includes treatment procedure.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a literature report detected on 20-oct-2021.The case report was described in zhu c, matz r, lewin-smith m, strausborger s, wohltmann w.Migrated bulking material (solesta) presenting as a vaginal "cyst": histopathologic and chemical analytical features.International journal of gynecological pathology.2021; 00 (1-4).Performing injections with a bulking agent consisting of nonanimal stabilized hyaluronic acid and dextranomer is a well-tolerated and efficacious treatment for mild to moderate fecal incontinence.Here, we discuss a case of a patient with a history of a bulking procedure for fecal incontinence who presented to the obstetrics/gynecology clinic for evaluation of a new vaginal "cyst," which was excised.Histopathologic examination revealed migrated bulking agent within the excised specimen.A (b)(6) african american female presented to the obstetrics/gynecology clinic for a new "vaginal cyst." she reported a 2 to 3mo history of a nontender, nondraining lesion in her left anterior-lateral vaginal wall, which was excised and sent for pathology.Routine hematoxylin & eosin staining demonstrated submucosal foreign/exogenous material composed of weakly basophilic, irregularly shaped, gel like sheets, and colorless to weakly eosinophilic, round, refractile material with interspersed granular, fibrinoid eosinophilic debris, macrophages, and occasional "foreign body"-type multinucleated giant cells.The basophilic, irregularly shaped material (hyaluronic acid/hyaluronate) stained with mucicarmine while the round objects (dextran/dextranomer) did not.The basophilic material did not stain with periodic acid schiff with diastase while the round objects (dextran/dextranomer) did.Acid mucopolysaccharide stained both the basophilic and round material.The basophilic material was almost entirely removed by hyaluronidase while the round material remained when stained with acid mucopolysaccharide with hyaluronidase.The histochemical findings supported the presence of a material composed of 2 components, one of which was consistent with hyaluronic acid/hyaluronate.Hyaluronic acid has been used as a dermal filler commonly for cosmetic purposes on the face and less commonly in other locations, to include the vagina.A thorough review of the patient's medical records failed to show a history of cosmetic procedures but did reveal a long history of fecal incontinence for which she had undergone a bulking procedure with solesta, which is composed of dextranomer and hyaluronic acid.On scanning electron microscopy/energy dispersive x-ray analysis the material consisted of carbon (c) and oxygen (o) showing slightly elevated oxygen (o) as compared with tissue.This nonspecific finding is consistent with hyaluronic acid and dextranomer along with other materials.Infrared spectroscopy was subsequently performed.Spectra obtained from the authentic sample of solesta was compared with spectra from the foreign material in an unstained tissue section mounted on an aluminized slide.Accounting for the spectral peaks from background tissue protein, the spectra obtained from the foreign material are consistent with spectra obtained from the authentic sample of solesta.Using scanning electron microscopy/energy dispersive x-ray analysis, a technique for elemental analysis, and infrared spectroscopy, a method of molecular characterization of unknown materials which uses comparisons to spectra of known authentic samples, the "vaginal cyst" in our case was consistent with a pool of solesta from a prior bulking procedure.Pathologists should be aware that hyaluronic acid is used in the treatment of fecal incontinence and should consider the possibility that unusual mucicarminophilic material associated with a "foreign body"-type reaction may represent material that has migrated from the deep submucosal tissue planes of the anal canal into the vaginal wall.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, TX 76177
• MDR Report Key: 12844302
• MDR Text Key: 285944744
• Report Number: 9710154-2021-00073
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2021

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: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/19/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female