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 2020-02-12 for XACT CAROTID 82090-01 manufactured by Abbott Vascular.
[179243901]
The device was not returned for evaluation. 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 and/or complaints. The investigation determined that the reported difficulties were likely due to case circumstances. Based on the reported information, the difficulty removing was due to resistance with the anatomy. 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
[179243902]
It was reported that the procedure was performed to treat a lesion in the left carotid artery. An emboshield nav6 embolic protection system (eps) was advanced without issues. Following pre-dilatation, an 8x40mm xact stent system was advanced and the stent was deployed. An attempt to remove the stent delivery system was made; however, resistance with the anatomy was felt. The 6f introducer sheath was advanced over the delivery system and they were removed as a unit. The nav6 eps was removed without issues. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01427 |
| MDR Report Key | 9701560 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Model Number | 82090-01 |
| Catalog Number | 82090-01 |
| Lot Number | 9092461 |
| 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 | 2020-02-12 |