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 2020-02-13 for XACT CAROTID XRX04009T manufactured by Abbott Vascular.
[179317918]
Event estimated dates. Visual analysis was performed on the returned device. The reported kink was confirmed. 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 identified no other incidents. The investigation determined that kink likely occurred during use. It is likely that the shaft kink occurred during advancement in the anatomy. Follow up to the account confirmed that the hypotube jacket material that was pulled away from the guide wire exit port did not occur during use. It is likely that the damage occurred during packaging the product for return to abbott. 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
[179317919]
It was reported that the delivery system of a xact carotid stent system was creased [kinked]. The stent system was advanced into the patient anatomy; however, as soon as the crease was noted it was removed and not deployed. The procedure was successfully completed with a new xact carotid stent. There were no adverse patient effects and no clinically significant delay in the procedure. The returned device analysis identified that the tapered proximal end of the guide wire exit port was pulled away from the hypotube jacket material. No sections of the jacket material or proximal end of the guide wire exit port appear to be missing. Follow-up with the account stated that this damage did not occur during the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01474 |
| MDR Report Key | 9707772 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-08-19 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2020-02-13 |
| 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 | XACT CAROTID |
| Generic Name | SELF EXPANDING PERIPHERAL STENT SYSTEM |
| Product Code | NIM |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-04 |
| Catalog Number | XRX04009T |
| Lot Number | 7121261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-13 |