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 2020-01-14 for XACT CAROTID 82090-01 manufactured by Abbott Vascular.
[175035684]
(b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effects of stroke, seizure and myocardial infarction are listed in the xact instructions for use as known potential patients effects associated with carotid stents and embolic protection systems. Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[175035685]
It was reported that post implantation of an xact stent in the left common carotid artery, the patient experienced an ischemic stroke, seizure and a myocardial infarction. Computed tomography (ct) of the brain confirmed the ischemic infarct. Medication was administered. Patient remains in poor condition. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-00688 |
| MDR Report Key | 9589474 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2019-12-24 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2020-01-14 |
| 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 | 2020-01-14 |
| Catalog Number | 82090-01 |
| Lot Number | 9061961 |
| 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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-01-14 |