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 2020-03-23 for WALLSTENT RP ENDOPROSTHESIS 26270 manufactured by Boston Scientific Corporation.
[184472014]
Device evaluated by mfr. : the device was returned with the stent separated from the delivery system. The stent was not returned for analysis. A visual and microscopic examination identified no damage or issues with the stent cups or the stent holder. The stent impression was evident on the stent holder. A visual and tactile examination found the outer to be severely kinked at more than one location. This type of damage is consistent with excessive force being applied to the device. A visual examination of the inner shaft found it to be completely detached from the metal shaft at its bond. This type of damage is consistent with excessive tensile force being applied to the device. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[184472015]
Reportable based on device analysis completed on (b)(6) 2020. A 10x69x75/ iliac 6f unistep plus wallstent rp endoprosthesis was used with no known issues reported. However, returned device analysis revealed stent detachment and shaft break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03695 |
| MDR Report Key | 9865591 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-02-23 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WALLSTENT RP ENDOPROSTHESIS |
| Generic Name | STENT, CORONARY |
| Product Code | NIO |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 26270 |
| Catalog Number | 26270 |
| Lot Number | 0021784276 |
| Device Expiration Date | 2020-02-23 |
| 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 | 2020-03-23 |