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 2020-03-20 for OMNILINK ELITE 1012630-29 manufactured by Abbott Vascular.
[184367448]
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Na
Patient Sequence No: 1, Text Type: N, H10
[184367449]
It was reported the procedure was to treat a severely tortuous and mildly calcified lesion in the iliac artery. The 7. 0x29mm omnilink elite stent delivery system (sds) was advanced however failed to cross the lesion. During retraction, the stent struts became flared and interacted with the 6fr sheath, causing resistance. The sds was able to be retracted into the sheath and removed from the anatomy. An absolute pro stent was used to complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02770 |
| MDR Report Key | 9863176 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 1012630-29 |
| Catalog Number | 1012630-29 |
| Lot Number | 8110141 |
| 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 | 6 | 2020-03-20 |