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 2020-03-17 for OMNILINK ELITE 1012623-39 manufactured by Abbott Vascular.
[186761599]
The incident information was reviewed; however, the product was not returned to abbott vascular for analysis. 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 similar incidents reported from this lot. The investigation determined the reported difficulties of difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure. Based on the reported information, the selected device size chosen for the procedure was too short to cover lesion. During retraction, the sds encountered resistance with the anatomy and/or other devices used causing the stent to dislodge on the wire. Manipulation during attempt to retrieve the stent using a snare device caused the stent to get stuck on the previously implanted stent. Additionally, the treatment appears to be related to the operational context of the procedure as a non-abbott covered stent was used to cover the entire area and embed the dislodged stent to the vessel wall. There is no indication of a product quality issue with respect to the design, manufacture.
Patient Sequence No: 1, Text Type: N, H10
[186761600]
It was reported that the patient arrived emergently with a groin bleed from a previous procedure. The physician cut down to the femoral/popliteal artery to bypass directly. Imaging was taken and the bleed was visualized and an 8fr sheath was inserted to attempt bypass. A 7. 0x39 mm omnilink elite stent was implanted without issue. An abdominal angiogram was performed and tight stenosis on the left iliac was noted. The physician called for another 7. 0x39 mm omnilink elite stent and it was advanced up and over the iliac crest only on a guide wire as the sheath was only on the right side. Once the omnilink reached the lesion it was found that the stent was too short. During removal of the omnilink elite sds the stent dislodged and was not noted until the delivery system was pulled out. The stent remained on the guide wire. A snare was used to bring the stent to the right side; however, the stent became stuck on the previously implanted omnilink elite stent. A non-abbott covered stent was then used to cover the entire area and embed the dislodged stent to the vessel wall. There was a delay in the procedure. There were no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02569 |
| MDR Report Key | 9845440 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | 1012623-39 |
| Catalog Number | 1012623-39 |
| Lot Number | 9032641 |
| 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 | 2020-03-17 |