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 2020-01-09 for XACT CAROTID 82090-01 manufactured by Abbott Vascular.
[178346314]
Exemption number e2019001. The device remains in the patient. 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
[178346315]
It was reported that the procedure was performed to treat an internal carotid artery. The 8x40mm xact stent was implanted on (b)(6) 2019. On (b)(6) 2019, the patient was re-examined due to dizziness. It was then found that the xact stent was separated and the vessel was re-stenosed. The patient is being treated with medication. There was no adverse patient sequela reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-00522 |
| MDR Report Key | 9571958 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | 82090-01 |
| Catalog Number | 82090-01 |
| Lot Number | 9041161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-09 |