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 2019-12-26 for ACCULINK 1011343-30 manufactured by Abbott Vascular.
[178169025]
Exemption number e2019001. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[178169026]
It was reported that the procedure was performed to treat a lesion in the right internal carotid artery. A 6-8x30mm acculink self-expanding stent system (sess) was advanced to the lesion successfully. During deployment, the stent became exposed for 1-2mm and would not deploy any further. The sess was removed successfully, and a new same size accullink stent was used to successfully complete the procedure. There were no issues with the deployment mechanism. 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 | 2024168-2019-14973 |
| MDR Report Key | 9520024 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-26 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-08 |
| Device Manufacturer Date | 2019-03-28 |
| Date Added to Maude | 2019-12-26 |
| 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 | ACCULINK |
| Generic Name | CAROTID STENT |
| Product Code | NIM |
| Date Received | 2019-12-26 |
| Returned To Mfg | 2019-12-28 |
| Model Number | 1011343-30 |
| Catalog Number | 1011343-30 |
| Lot Number | 9032861 |
| 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 | 2019-12-26 |