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 2019-03-18 for EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM 22438-19 manufactured by Av-temecula-ct.
[139088732]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot revealed no other similar incidents reported for this lot. The reported patient effect of embolism is listed in instructions for use (ifu) emboshield nav6 embolic protection system (eps) as a known patient effect(s) of the procedure. It should be noted that emboshield nav6 eps ifu states: the emboshield nav6 rapid exchange (rx) eps is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. Additionally, the emboshield nav6 device can only be used with the barewire filter delivery wire. Use of the device with any guide wire other than the barewire filter delivery wire will lead to loss of the filtration element during the procedure or an inability to retrieve the filtration element. In this case, the guide wire used in the procedure was not compatible with the eps, as the stop was missing from the wire which prevents the filter from migrating or detaching off the eps barewire. The investigation determined the reported difficulties of difficulty to remove and migration of device component appears to be related to the use error. In this case, based on the reported information, the guide wire used in the procedure was not compatible with the eps, as the stop was missing from the wire which prevented the filter from migrating or detaching off the eps barewire. However, the reported embolism and treatments appear to be related to the operational context of the procedure as a snare device was used to retrieve the filtration element from the anatomy. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[139088733]
It was reported that the patient presented with a popliteal artery, heavily calcified lesion. A 6 french sheath was inserted up and over to the lesion site. An emboshield nav 6 embolic protection system advanced over a viper guide wire (not the supplied barewire) and atherectomy was performed. Following, the filter basket was too full and difficulty was encountered retrieving this basket into the retrieval catheter. Additional aspiration was performed, however, the filter basket was still difficult to retrieve. The filter then dislodged from the wire into the common femoral artery. Snare removal was attempted, however, the filter then embolized to the profunda. Once in the profunda, the snare successfully retrieved the device. The procedure continued with stent placement and without further issues. There was no clinically significant delay and there was no adverse patient sequela. No additional information was provided regarding this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-02093 |
| MDR Report Key | 8429039 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-18 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2019-03-18 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
| Generic Name | EMBOLIC PROTECTION SYSTEM |
| Product Code | NTE |
| Date Received | 2019-03-18 |
| Catalog Number | 22438-19 |
| Lot Number | 8121761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-18 |