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 2020-03-09 for OMNILINK ELITE 1012631-59 manufactured by Abbott Vascular.
[182561169]
Visual analysis was performed on the return device. The reported stent dislodgement was not confirmed; however, the stent had moved proximally on the balloon. 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 complaints from this lot. Based on the reported information, the stent damage and movement on the balloon likely occurred during removal of the protective sheath, or inadvertent mishandling during preparation. 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
[182561170]
It was reported that during preparation, the 8. 0x59mm omnilink elite stent dislodged from the catheter. There was no patient involvement. A new unspecified device was used to continue the procedure. 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 | 2024168-2020-02151 |
| MDR Report Key | 9805377 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-08-23 |
| Date Added to Maude | 2020-03-09 |
| 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 # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNILINK ELITE |
| Generic Name | PERIPHERAL STENT DELIVERY SYSTEM |
| Product Code | NIO |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-24 |
| Model Number | 1012631-59 |
| Catalog Number | 1012631-59 |
| Lot Number | 9082341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-09 |