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 2020-02-05 for RX HERCULINK ELITE STENT SYSTEM 1011487-15 manufactured by Abbott Vascular.
[177952925]
The device was discarded and will not return for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[177952926]
It was reported that on (b)(6) 2020, a percutaneous intervention was performed, to treat the right renal artery. Balloon angioplasty was performed and a herculink elite stent delivery system (sds) advanced when resistance was noted due to anatomy. During sds retraction, resistance was felt with anatomy and the stent dislodged from the delivery system. The stent was partially in the aorta and partially in the right renal artery. Snare was used to successfully retrieve the device. Nothing was left in the patient's anatomy. It was decided to complete the procedure without placing a stent. There was no adverse patient sequela and there was no clinically significant delay. No additional information was provided regarding this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01236 |
| MDR Report Key | 9673319 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2018-02-06 |
| Date Added to Maude | 2020-02-05 |
| 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 # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX HERCULINK ELITE STENT SYSTEM |
| Generic Name | STENT, RENAL |
| Product Code | NIN |
| Date Received | 2020-02-05 |
| Model Number | 1011487-15 |
| Catalog Number | 1011487-15 |
| Lot Number | 8020661 |
| 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 | 2020-02-05 |