MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-05 for XACT CAROTID STENT SYSTEM XRX04008T manufactured by Av-temecula-ct.
[137847751]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other similar incidents. The investigation determined the reported difficulties were due to case circumstances. It is likely that the shaft of the sess was restricted in the challenging anatomy creating built up tension within the shaft lumens causing a spring like release of the stent when released from the delivery system. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[137847752]
It was reported that the procedure was performed to treat a tight [narrow] lesion at the bifurcation of the internal carotid artery and the common carotid artery. A 40x8-6 mm x-act freestyle tappered self-expanding stent system (sess) was advanced to the lesion with resistance from the anatomy. On attempting to deploy the stent, the stent jumped 1-1. 5 cm distally leaving part of the target lesion uncovered. An additional 40x8-6 mm x-act stent was successfully deployed to complete the case and treat the remainder of the lesion. There were no adverse patient effects and no reported clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-01683 |
| MDR Report Key | 8391050 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-02-23 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2019-03-05 |
| 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 | XACT CAROTID STENT SYSTEM |
| Generic Name | CAROTID STENT SYSTEM |
| Product Code | NIM |
| Date Received | 2019-03-05 |
| Catalog Number | XRX04008T |
| Lot Number | 8102961 |
| 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 | 2019-03-05 |