MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for MO.MA ULTRA manufactured by Invatec Spa.
[188139273]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188139274]
It was reported in the literature article, incidence and predictors of calcified cerebral emboli detected in patients who underwent endovascular procedures, that a study was carried out to evaluate the incidence rates and predictors of calcified cerebral emboli in patients who underwent carotid artery stenting (cas)/percutaneous transluminal angioplasty (pta) between 2014? 2018. Mo. Ma ultra and spider fx devices were used in the study along with other non-medtronic devices. A total of 211 consecutive patients with cervical internal carotid stenosis were included in this study. Patients were categorized according to the presence of calcified cerebral emboli in postoperative computed tomography (ct) into emboli and non-emboli groups. Calcified emboli were defined as a ct value of 60? 400 hounsfield units (hu). On postoperative non-contrast ct, calcified emboli were detected in 5 of the 211 cases after cas/pta. The emboli were located in the middle cerebral artery (2/5), anterior cerebral artery (1/5), posterior cerebral artery (2/5). All of the cases of calcified cerebral emboli were clinically asymptomatic. In 3 of the 5 patients (60 %), the calcified emboli were located in the right hemisphere, whereas in the other 2 patients (40 %), the calcified emboli were located in the left hemisphere. The mean ct value was 92 hu (range of 60? 316 hu). The proximal epd (including mo. Ma ultra) were not used in the emboli group and used in 31. 6 % (65/206) in the non-emboli group.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004066202-2020-00009 |
| MDR Report Key | 9781180 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-03 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | INVATEC SPA |
| Manufacturer Street | VIA MARTIRI DELLA LIBERTA, 7 |
| Manufacturer City | RONCADELLE 25030 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 25030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MO.MA ULTRA |
| Generic Name | CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE |
| Product Code | NTE |
| Date Received | 2020-03-03 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVATEC SPA |
| Manufacturer Address | VIA MARTIRI DELLA LIBERTA, 7 RONCADELLE 25030 IT 25030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-03 |