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 2020-03-13 for OMNILINK ELITE 1012624-19 manufactured by Abbott Vascular.
[183482749]
The device was not returned for evaluation as the stent remains implanted. 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 indication of a lot specific product quality issue. Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure. It is likely that the omnilink elite stent could not be fully expanded due to the anatomy, thus preventing the non-abbott catheter from being able to advance through the stent. Additionally, if the omnilink elite stent was not fully apposed to the vessel wall, it is likely that the guide wire became trapped within the stent resulting in difficulty removing and unraveling of the guide wire tip coils. 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
[183482750]
It was reported that the procedure was to treat a stenosed left pulmonary artery. An 8. 0x19mm omnilink elite stent was inflated at 14 atmospheres and deployed in the lesion. Then a non-abbott catheter was advanced over the stiff guide wire in order to measure pressure difference of the distal part of the deployed stent; however, the catheter did not advance through the omnilink stent. Therefore, the non-abbott catheter was replaced with another non-abbott catheter; however, that catheter did not advance either. An attempt was made to remove the stiff guide wire; however, the stiff guide wire could not be removed and became unraveled. On the same day, surgical treatment was performed to remove the guide wire. Per the physician, it is possible the omnilink elite stent could not be fully expanded due to the anatomy and the guide wire became trapped in the stent. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02422 |
| MDR Report Key | 9831940 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Model Number | 1012624-19 |
| Catalog Number | 1012624-19 |
| Lot Number | 8121141 |
| 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 | 2020-03-13 |