MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-30 for PROMUS ELEMENT 9305 manufactured by Boston Scientific Corporation.
[185666484]
Device is a combination product.
Patient Sequence No: 1, Text Type: N, H10
[185666485]
It was reported that stent damage occurred. The target lesion was located in the tortuous and severely calcified left anterior descending artery. A 3. 00x16mm promus element drug-eluting stent was advanced but failed to cross the lesion. After withdrawal, it was noted that the struts were lifted. The procedure was completed with another of the same device. No patient complications were reported and patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04082 |
| MDR Report Key | 9898453 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2020-03-30 |
| 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 CORPORATION |
| 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 | PROMUS ELEMENT |
| Generic Name | STENT, CORONARY, DRUG-ELUTING |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Model Number | 9305 |
| Catalog Number | 9305 |
| Lot Number | 0022634810 |
| Device Expiration Date | 2020-03-08 |
| 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 | 2020-03-30 |