MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for SOLESTA manufactured by Palette Life Sciences.
[132370960]
Pharmacovigilance comment: the serious events of implant site nodule and device dislocation were considered expected and possibly related to the treatment. Serious criteria include an important medical event due to the extended 10-year duration of the implant site nodule and the need for surgical intervention to rule out and prevent potential permanent harm such as colorectal malignancy. The reported reason for the surgery was diagnostic confounding associated with the identity of the nodules and the fact that they had migrated to a cephalad location. Potential contributory factors for the events included injection technique, inability to obtain smaller biopsies of the implant due to product firmness, limitations in radiography that placed the nodules in the muscularis propria, and further diagnostic confounding given risk factors for colon cancer of diabetes, obesity and previous colorectal polypectomy. The non-serious, unexpected events of abdominal pain and dyspepsia were considered unrelated to the treatment. Abdominal pain was considered unexpected due to the event duration. Potential etiologies for the abdominal symptoms include diabetic complications such as diabetic gastroparesis and enteropathy, associated with poor glycemic control and autonomic dysfunction. Potential risk factors for the abdominal symptoms include diabetic medications, female gender and obesity. The case meets the criteria for expedited reporting to the regulatory authorities. Manufacturer narrative: lot number was not reported. Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.
Patient Sequence No: 1, Text Type: N, H10
[132370961]
This case is a literature report sent on 31-oct-2018 by med info. Tiernan et al. An unusual case of submucosal rectal nodules. Gastroenterology journal. 2018; volume 155: issue 4, pages e5-e6. A (b)(6)-year-old woman with a history of nonalcoholic fatty liver disease presented to the gastroenterology outpatient office with a 1-year history of chronic right lower quadrant abdominal pain and heartburn. She denied any association with oral intake, weight loss, or rectal bleeding. She had a history of type ii diabetes, obesity, hemorrhoids, and unspecified treatment for fecal incontinence in the remote past. During screening colonoscopy performed 7 years prior, a diminutive lipomatous colonic polyp was removed. A computed tomography scan of the abdomen and pelvis was obtained and was normal. Colonoscopy was performed for further evaluation and was notable for 3 separate submucosal nodules in the rectum, measuring 8 to 10 mm in size, lying approximately 8 cm from the anal verge. On endosonography, the lesions were hypoechoic and seemed to originate from the muscularis propria in the distal rectum. The lesions were firm and did not demonstrate the pillow sign. Bite-on-bite and tunneling biopsies were unsuccessful at obtaining any diagnostic tissue from these mobile lesions. She was, therefore, referred to colorectal surgery for transanal excision. The lesions were mobile, submucosal, firm, smooth, and regular. The largest was resected via a transanal submuscular dissection, excision, and primary closure. The tissue was sent for histopathologic analysis and the patient was discharged on the same day. She had an uneventful recovery. Histopatholgic analysis of the lesion was consistent with a synthetic filler. On further questioning and review of hospital records, it became apparent that the patient had undergone injection of solesta as treatment for mild fecal incontinence 10 years before her presentation. The material had evidently migrated cephalad in the submucosal plane. The use of injectable filler as a treatment for incontinence was first described by shafik et al in 1993, and multiple observational studies have been published describing various agents including silicone, collagen, and carbon-coated beads. Solesta, a dextranomer in hyaluronate, is the only injectable agent approved by the us food and drug administration for the treatment of fecal incontinence in the united states. It is injected via the perineal skin into the plane between the internal sphincter and the submucosa at the level of the anal canal just above the dentate line, and acts as a bulking agent. There has been 1 randomized, controlled trial comparing injection with a sham procedure, which demonstrated a significant decrease in incontinence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014909464-2018-00001 |
| MDR Report Key | 8224238 |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-07 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2019-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CLIFF KLINE |
| Manufacturer Street | 27 E. COTA STREET SUITE 402 |
| Manufacturer City | SANTA BARBARA CA 93101 |
| Manufacturer Country | US |
| Manufacturer Postal | 93101 |
| Manufacturer Phone | 8058697056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOLESTA |
| Generic Name | SOLESTA INJECTIBLE GEL |
| Product Code | LNM |
| Date Received | 2019-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALETTE LIFE SCIENCES |
| Manufacturer Address | 27 E. COTA STREET SUITE 402 SANTA BARBARA CA 93101 US 93101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-07 |