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 2019-03-20 for VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM PXB35-07-27-080 manufactured by Covidien.
[139326059]
Device evaluation: visual inspection: the visi-pro showed the stent loaded over the balloon. One of the distal struts of the stent was stretched out in the distal direction. No fracture was noted. No other damages to the visi-pro device was observed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139326060]
Physician attempted to use a visipro with a non-medtronic 6fr sheath (cordis) and 0. 035 guidewire (magic torque) to treat a plaque lesion with 90% stenosis in the left proximal renal artery. The artery diameter was 7mm and the vessel presented moderate tortuosity. Ifu was followed and the device was prepped with no issues noted. It was reported that the physician encountered difficulty when attempting to cross the stenosis. Plain old balloon angioplasty (poba) was used to pre-dilate the vessel. On second attempt, the stent could not make the 90 degree turn, so the catheter was removed. A 6x17 stent was used and during insertion. A shadow was noted on the guidewire. The previously used stent catheter was checked and the stent was missing. In the process of pulling the wire back, the stent came off the wire and was free floating in the aorta. An amplatz snare was inserted and removed the stent in its entirety. The procedure was not completed. When the device was returned to the manufacturing facility, it was noted that the stent was damaged
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2019-00137 |
| MDR Report Key | 8435821 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-03-15 |
| Device Manufacturer Date | 2018-11-13 |
| Date Added to Maude | 2019-03-20 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 4600 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-02-09 |
| Catalog Number | PXB35-07-27-080 |
| Lot Number | A739616 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-20 |