MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-28 for MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM MIN9770 manufactured by Minerva Surgical, Inc..
[181491939]
The doctor stated that at the time of surgery, the uterus did not have any evidence of mechanical perforation, but a transmural type thermal injury into the fundal serosa and adjacent bowel was present. Doctor also indicated that according to the information presented to her, the patient likely suffered from a previously undiagnosed uterine hypoplasia of some form, as it was reported that the fundal myometrium was extremely and abnormally thin, which likely was the root cause of the reported adverse event. This scenario is described in the contraindications section of the minerva ifu which states: the minerva endometrial ablation system is contraindicated for use in a patient with any anatomic condition (e. G. , history of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the minerva procedure) or pathologic condition (e. G. , requiring long-term medical therapy) that could lead to weakening of the myometrium.
Patient Sequence No: 1, Text Type: N, H10
[181491940]
It was reported that an uneventful minerva procedure was performed in a (b)(6) years old patient suffering from aub (e). Post-treatment hysteroscopy was performed. Evidence of adequate distention and ablation was present. The patient was discharged shortly after the procedure. Approximately 3 days later the patient went to the er complaining of acute lower abdominal pain. Ct-scan was performed, and free gas was seen. Bowel injury was suspected, and the patient was transferred to a different institution. Doctor stated that at the time of surgery, the uterus did not have any evidence of mechanical perforation, but a transmural type thermal injury into the fundal serosa and adjacent bowel was present. Doctor also indicated that according to the information presented to her, the patient likely suffered from a previously undiagnosed uterine hypoplasia of some form, as it was reported that the fundal myometrium was extremely and abnormally thin, which likely was the root cause of the reported adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011011193-2020-00004 |
| MDR Report Key | 9772268 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2017-09-13 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELSIE WELLS |
| Manufacturer Street | 101 SAGINAW DRIVE |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3991787 |
| Manufacturer G1 | MINERVA SURGICAL, INC. |
| Manufacturer Street | 101 SAGINAW DRIVE |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM |
| Generic Name | ENDOMETRIAL ABLATION DEVICE |
| Product Code | MNB |
| Date Received | 2020-02-28 |
| Model Number | MIN9770 |
| Catalog Number | MIN9770 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINERVA SURGICAL, INC. |
| Manufacturer Address | 101 SAGINAW DRIVE REDWOOD CITY, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-28 |