MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for OMNILINK ELITE 11005-59 manufactured by Abbott Vascular.
[187171439]
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 complaints. Based on the information provided, a cause for the reported difficulties could not be determined. It may be possible that the non-abbott 6fr sheath was not the appropriate id; however, this could not be confirmed. The stent dislodgment likely occurred to the stent becoming loose on the balloon and ultimately dislodging during the attempt to re-insert into the 7f introducer sheath. 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
[187171440]
It was reported that the procedure was to treat the iliac artery. The 9. 0x59 mm omnilink elite stent was advanced in a 6fr introducer sheath with resistance. It was recommended to switch to a 7fr sheath and the omnilink elite was re-inserted. It was noted then that the stent was not the correct size so the sds was removed. After removal, the stent was not on the delivery system and it was noted to be located in the primitive iliac artery. A balloon dilatation catheter (bdc) was used to deploy the dislodged stent which was located before the target lesion. Another stent was used to treat the target lesion. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02780 |
| MDR Report Key | 9871588 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Catalog Number | 11005-59 |
| Lot Number | 9082641 |
| 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. Required No Informationntervention | 2020-03-24 |