MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-13 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[144836113]
Patient's weight unavailable from facility.
Patient Sequence No: 1, Text Type: N, H10
[144836114]
A coronary vascular intervention procedure commenced to treat an in-stent restenosis of the mid left anterior descending (lad) artery. This was reported to be a very difficult case at the onset. The target lesion was a distal lad stent that had restenosed. The lad was very torturous and it took the physician a bit to wire, but was successful. The doctor then tried to pass the spectranetics elca device to the restenosed stent. It was reported that the elca laser was never fired in the vessel; instead, the device was just manually advanced down the artery. He felt slight resistance and stopped advancing the laser. He then removed the laser to try and pass a second wire down the vessel, but was unable. He tried again to put a second wire down the vessel, and again was unsuccessful at putting the wire down the vessel. An angiogram was performed and a new lesion was observed, proximal to the target lesion. After a balloon was placed in the new lesion site and inflated, the physician observed a significant dissection. The physician reportedly thought the elca device might have created the dissection. He then placed a stent synergy in the dissected part of the vessel and post dilated with a balloon. This procedure reportedly took quite a while so by this time the amount of x-rays were over dosage. The physician could not get the restenosed distal stent to yield with a balloon only, so the physician consulted surgery to see if they would operate or if he needed to bring the patient back to try to fix the restenosed stent at a later date. Through all of this the patient remained hemodinamically stable, and survived the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00073 |
| MDR Report Key | 8603876 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-13 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-04-18 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2019-05-13 |
| 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 | MRS. BARBARA CREEL |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-05-13 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG019C05A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-05-13 |