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 2020-02-18 for RX HERCULINK ELITE STENT SYSTEM 1011533-18 manufactured by Abbott Vascular.
[180827725]
(b)(4). The stent remains in patient. The device will not be returned 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
[180827726]
It was reported that a 6x18mm herculink elite stent delivery system (sds) was deployed, but the stent was expanded to 5mm at 15 atmospheres (atms). After further manipulation, the stent expanded to 5. 5mm, which is the same as the diameter of the artery. The stent could not fix [be apposed], so an unspecified 7mm stent was used to successfully complete the procedure. There were no adverse patient sequelae and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01562 |
| MDR Report Key | 9720258 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2017-02-16 |
| Date Added to Maude | 2020-02-18 |
| 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 | 2020-02-18 |
| Catalog Number | 1011533-18 |
| Lot Number | 7021661 |
| Device Expiration Date | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-18 |