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 2020-02-12 for EMBOSHIELD NAV 6 UNK EMBOSHIELD NAV6 manufactured by Abbott Vascular.
[180369822]
Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated. The device was not returned for analysis. The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported. The reported patient effects of cerebrovascular accident, hypotension and pain are listed in the emboshield nav6 instruction for use (ifu), as known possible adverse events that may be associated with the use of the device. Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. The additional therapy/non-surgical treatment was due to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling. The two additional emboshield nav6 embolic protection system (eps) devices referenced are being filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[180369823]
It was reported that the procedure was performed to treat a lesion in the carotid artery. An unspecified stent was deployed in the carotid artery six months ago and the patient was re-hospitalized on (b)(6) 2020 with in-stent stenosis thought to be thrombosis. An emboshield nav6 embolic protection system (eps) was advanced and the filter was deployed; however, it was realized that a 300centimeter (cm) guide wire was needed in order to use the proposed suction catheter. The filter was removed without issues. A 300cm guide wire was advanced and a second nav6 filter was advanced; however, the guide wire was pulled in accident and the filter moved from its desired location. The filter was removed without issues. The same thing happened with a third nav6 filter and it was removed without issues. A fourth nav6 filter was advanced and the guide wire was locked in place to the sheath; however, the patient experienced groin pain and their blood pressure dropped. The physician started the pace maker that was already in place through the venous access sheath. The nav6 filter was removed without issues and the case was aborted. The patient suffered a mild stroke and was rushed to computed tomography and stroke protocols were put in place. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01433 |
| MDR Report Key | 9701884 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-12 |
| 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 | 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 | 2020-02-12 |
| Catalog Number | UNK EMBOSHIELD NAV6 |
| 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 | 1. Required No Informationntervention; 2. Deathisabilit | 2020-02-12 |