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 2020-01-21 for WALLSTENT ENDOPROSTHESIS 26280 manufactured by Boston Scientific Corporation.
[178218540]
Device evaluated by mfr. :the device was returned for analysis. The stent was returned fully mounted in the correct location on the delivery system. The investigator successfully deployed the stent with no resistance or issues experienced. A visual and microscopic examination identified damage to the distal stent wires of the deployed stent. This type of damage is consistent with the stent encountering resistance during deployment. A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device. A visual and tactile examination identified no issues with the tip of the device. A visual and tactile examination found no damage or issues with the shaft of the returned device. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[178218541]
Reportable based on device analysis completed on 06jan2020. It was reported that stent deployment failure occurred. The target lesion was located in the inferior vena cava vein. A 24x45/11fr uni plus 75cm wallstent endoprosthesis was advanced for treatment. However, the distal end of the stent would not open up when tried to deploy. Subsequently, the physician reconstrained the stent and tried to deploy it again but was unsuccessful. The device was then removed in a fully reconstrained state and another 22x45 wallstent was used to complete the procedure. No patient complications were reported. However, returned device analysis revealed stent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00282 |
| MDR Report Key | 9612216 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2020-01-21 |
| 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 | WALLSTENT ENDOPROSTHESIS |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | JCT |
| Date Received | 2020-01-21 |
| Returned To Mfg | 2019-12-06 |
| Model Number | 26280 |
| Catalog Number | 26280 |
| Lot Number | 0023723572 |
| 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 | 2020-01-21 |