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 2020-03-30 for PROMUS PREMIER 9553 manufactured by Boston Scientific Corporation.
[185666818]
Device is a combination product.
Patient Sequence No: 1, Text Type: N, H10
[185666819]
It was reported that stent damage occurred. The 3. 8mm in diameter, diffused target lesion was located in the tortuous and severely calcified middle and distal end of the right coronary artery. A 32 x 4. 00 promus premier stent was advanced for treatment. However, the stent struts were lifted and the device could not cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04101 |
| MDR Report Key | 9900071 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-05-09 |
| 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 PREMIER |
| Generic Name | STENT, CORONARY, DRUG-ELUTING |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Model Number | 9553 |
| Catalog Number | 9553 |
| Lot Number | 0023794717 |
| 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 |