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 2020-01-28 for XACT CAROTID XRX03007S manufactured by Abbott Vascular.
[177389703]
The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[177389704]
It was reported that the procedure was to treat a moderately tortuous internal carotid artery. During the procedure, it was noted that a x-act freestyle straight 30x7 carotid stent system suffered warping (bend) at the guide wire exit notch. Another stent was used to successfully complete the procedure. There was no adverse patient effects or clinically significant delay. No additional information was reported. 1/3/2020: device analysis noted that the support wire was separated at 3. 7cm from noted torn shaft. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-00931 |
| MDR Report Key | 9637769 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-28 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2017-01-16 |
| Date Added to Maude | 2020-01-28 |
| 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 | 2020-01-28 |
| Returned To Mfg | 2019-11-26 |
| Catalog Number | XRX03007S |
| Lot Number | 7011661 |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-01-28 |