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 2020-03-12 for INNOVA VASCULAR 26926 manufactured by Boston Scientific Corporation.
[183179155]
It was reported that partial stent deployment occurred. A 6x150x130 innova self-expanding stent was selected for a procedure in the heavily calcified superficial femoral artery (sfa). The lesion had minimal tortuosity and pre-dilation was performed with no yielding of the calcium. A contralateral approach was used to access the lesion. During deployment, the stent stopped deploying after 5cm. There was some difficulty removing the stent. The entire delivery system and stent were able to be pulled back into the sheath and removed. The procedure was completed without any stent being used and there were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02922 |
| MDR Report Key | 9824530 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-03-12 |
| 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 SCIMED, INC |
| 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 | 2020-03-12 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 26926 |
| Catalog Number | 26926 |
| Lot Number | 0024020807 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-12 |