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 2019-05-20 for RX HERCULINK ELITE RENAL STENT SYSTEM 1011490-12 manufactured by Av-temecula-ct.
[145499903]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[145499904]
It was reported that the procedure was to treat a de novo lesion in a mid right vertebral artery that was narrow and eccentric and was 90% stenosed. A 4. 5 x 12 mm herculink elite balloon expandable stent system was used; however, the balloon only partially inflated even after several attempts were made. Therefore, another 4. 5 x 12 mm herculink elite stent was implanted to successfully complete 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 | 2024168-2019-03930 |
| MDR Report Key | 8623644 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-05-20 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2019-05-20 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX HERCULINK ELITE RENAL STENT SYSTEM |
| Generic Name | STENT SYSTEM |
| Product Code | NIN |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-06-12 |
| Catalog Number | 1011490-12 |
| Lot Number | 8050461 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |