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 SYNERGY 10623 manufactured by Boston Scientific Corporation.
[187712333]
Device is combination product.
Patient Sequence No: 1, Text Type: N, H10
[187712334]
It was reported that stent migration occurred. The patient presented for a percutaneous coronary intervention with non-st elevation myocardial infarction (nstemi). The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified distal left main to left anterior descending artery (lad). Following predilatation, a 3. 0 x 38mm synergy ii drug eluting stent (des) was implanted in the ostium and a 2. 5 x 38mm synergy ii des was implanted in the mid lad overlapping the proximal stent. Post dilatation was performed with a 3. 0x12mm emerge balloon and when the balloon was removed, the proximal (3. 0 x 38mm) stent was suddenly gone. The stent had migrated to the subclavian artery but the physician was unable to catch it because the patient's condition was unstable. The physician tried again with a snare catheter but the stent was only pulled down to the ulnar artery. The patient's condition was good so the physician decided to follow up with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04048 |
| MDR Report Key | 9897567 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-21 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-09-05 |
| 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 | SYNERGY |
| Generic Name | CORONARY DRUG-ELUTING STENT |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Model Number | 10623 |
| Catalog Number | 10623 |
| Lot Number | 0024416487 |
| 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. Other | 2020-03-30 |