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 2020-03-31 for SYNERGY 10618 manufactured by Boston Scientific Corporation.
[185937322]
Device is a combination product. Device evaluated by mfr. : synergy ous mr 2. 50 x 16mm stent delivery system was returned for analysis. A visual and microscopic examination of the stent found mid stent damage, with stent struts lifted and pulled in a distal direction. The undamaged stent outer diameter was within maximum crimped stent profile measurement. The balloon cones were reviewed and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and microscopic examination of the bumper tip showed no signs of damage. A visual and tactile examination of the hypotube found no issues. A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[185937323]
Reportable based on device analysis completed on 10mar2020. It was reported that crossing difficulties were encountered. The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. Following pre-dilatation with a 2. 0x20 maverick balloon catheter, a 2. 50 x 16 synergy drug eluting stent was advanced but failed to cross procedure was completed with a different device. No patient complications were reported and the patient status was stabilized. However, returned device analysis revealed stent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04160 |
| MDR Report Key | 9903930 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-09-09 |
| 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 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 | 2020-03-31 |
| Returned To Mfg | 2020-02-19 |
| Model Number | 10618 |
| Catalog Number | 10618 |
| Lot Number | 0024441102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-31 |