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 2020-03-30 for INNOVA VASCULAR 26926 manufactured by Boston Scientific Corporation.
[186675922]
It was reported that the stent partially deployed and the stent stretched in the patient's anatomy. The 100% stenosed target lesion was located in the moderately calcified lesion superficial femoral artery (sfa). A contralateral approach was used to access the lesion. Pre-dilation was performed. A 7x150x130 innova self-expanding stent was selected for use over. 014/300 cm non-bsc guidewire. When the physician attempted to deploy the stent, it was unable to be fully deployed using the thumbwheel despite using much force. The pull grip was attempted to be used. The catheter was pulled back and the stent became stretched into the external iliac artery. A sheath dilator was used to push the deployment catheter out with the stent remaining implanted and stretched within the anatomy. The stent was not able to be removed. There were no immediate patient complications. However, the stent now sits across the common femoral artery (cfa), an area that bends and should not be stented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04016 |
| MDR Report Key | 9898137 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2020-01-15 |
| 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 | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVA VASCULAR |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Product Code | NIP |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 26926 |
| Catalog Number | 26926 |
| Lot Number | 0025041206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Required No Informationntervention | 2020-03-30 |