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 2019-04-08 for WALLSTENT RP ENDOPROSTHESIS 26265 manufactured by Boston Scientific Corporation.
[141234011]
It was reported that a stent migration occurred. The stenosed target lesion was located in an unknown artery. A 10x42x75 unistep plus stent self expanding was advanced for treatment however it foreshortened post deployment. Another 10x68x75 unistep plus stent self expanding was deployed. However, after checking the fluoroscopy, the stent migrated to the heart. The procedure was ended and the patient was transferred to another hospital for open heart surgery. The devices were removed by a cardiovascular surgeon. The patient status was stable post surgical explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-03603 |
| MDR Report Key | 8492567 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2019-02-15 |
| Date Added to Maude | 2019-04-08 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| 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 | WALLSTENT RP ENDOPROSTHESIS |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | MIR |
| Date Received | 2019-04-08 |
| Model Number | 26265 |
| Catalog Number | 26265 |
| Lot Number | 0023353620 |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-04-08 |