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 2020-03-31 for LOTUS EDGE VALVE SYSTEM 10394 manufactured by Boston Scientific Corporation.
[187262938]
It was reported that vessel perforation occurred. Procedure summary: patient anatomy was mildly tortuous. Annulus diameter was 26mm. Access site was right femoral vessel. During the insertion of the 27mm lotus edge valve into a large lotus introducer sheath (lis), high resistance was felt at 6cm to 10cm into the lis. The 27mm lotus edge valve was stuck inside the lis. An attempt to remove the lotus edge valve was not successful. Next an attempt to move the valve forward was done, and an audible pop was heard. The valve moved forward and the resistance suddenly disappeared. Fluoroscopy indicated that the proximal part of the lis moved forward into thoracic aorta with the proximal part of the lotus edge still inside the lis. The lotus edge valve and lis were removed together from the patient. The procedure completed with another large lis and a new 27mm lotus edge valve system. After a non-bsc closure device was used, strong bleeding in the right groin was seen. The perforation was treated with a femoral vessel stent. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03078 |
| MDR Report Key | 9903584 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-13 |
| Date Added to Maude | 2020-03-31 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOTUS EDGE VALVE SYSTEM |
| Generic Name | LOTUS EDGE TM VALVE SYSTEM 27 MM |
| Product Code | NPT |
| Date Received | 2020-03-31 |
| Model Number | 10394 |
| Catalog Number | 10394 |
| Lot Number | 0024588206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |