MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for EMBOSHIELD NAV 6 22445-31 manufactured by Abbott Vascular.
[182967462]
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The emboshield nav6 referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[182967463]
It was reported that the procedure was to treat a heavily tortuous, moderately calcified bifurcated superficial femoral artery. An emboshield nav6 was placed over the 315cm barewire and then introduced the non-abbott stream device over the bare wire. After the nav6 filter was successfully deployed, the non-abbott stream device was being pulled back, it was noted that the nav6 filter also shifted to the proximal direction even though the tip of the wire was not at the filter, but still in the below-the-knee vessels. It was attempted to push back the filter with a 5f diagnostic catheter but were unable to advance the filter. It was decided to continue the procedure at the position where the filter had moved and start atherectomy. After atherectomy was completed, they were unable to remove the non-abbott stream device from the bare wire, as it was stuck on it. All units (filter, bare wire, and non-abbott stream device) were removed altogether as a single unit. There was no adverse patient effects. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02256 |
| MDR Report Key | 9818158 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-03-11 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSHIELD NAV 6 |
| Generic Name | EMBOLIC PROTECTION SYSTEM |
| Product Code | NTE |
| Date Received | 2020-03-11 |
| Catalog Number | 22445-31 |
| Lot Number | 9060461 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |