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 2019-02-04 for WALLSTENT-UNI ENDOPROSTHESIS 26650 manufactured by Boston Scientific Corporation.
[134877755]
Device evaluated by mfr. : the device was returned for analysis. The stent was not returned for analysis. It is not known when the stent was deployed. No damage or issues were identified with the stent cup or stent holder that could potentially have contributed to the complaint incident. A visual and tactile examination identified no issues with the tip of the device. A visual and tactile examination identified multiple severe kinks on the shaft of the device. This type of damage is consistent with excessive force being applied to the delivery system. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[134877756]
Reportable based on device analysis completed on 14jan2019. It was reported that crossing difficulties were encountered. The target lesion was located in the stenosed inferior vena cava. Following pre-dilatation using an 8mm balloon catheter, a 22 x 45mm x 75cm wallstent-uni endoprosthesis stent was advanced but failed to cross the lesion. The device was removed and the procedure was completed with a different device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed stent was deployed and detached from the delivery system. It was further reported that the stent was damaged and probably not intact on the delivery system when removed from the patient. The stent did not dislodge from the system and remained in the delivery system upon removal. There were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-00709 |
| MDR Report Key | 8301298 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-02-04 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2016-12-20 |
| Date Added to Maude | 2019-02-04 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| 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-UNI ENDOPROSTHESIS |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | JCT |
| Date Received | 2019-02-04 |
| Returned To Mfg | 2019-01-02 |
| Model Number | 26650 |
| Catalog Number | 26650 |
| Lot Number | 0020100031 |
| Device Expiration Date | 2018-12-20 |
| 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 | 2019-02-04 |