MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-04 for UNKPULSERIDER manufactured by Pulsar Vascular.
[177653552]
(b)(4). Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. Device history record (dhr) review cannot be conducted because no lot number was provided by the customer. Information regarding patient weight, height, medical history, race, and ethnicity was not reported. Cerenovus manufacturer's report numbers: 3008680601-2020-00002, 3008680601-2020-00003, 3008680601-2020-00004, 3008680601-2020-00005, 3008680601-2020-00007, 3008680601-2020-00008. Are related to the same incident.
Patient Sequence No: 1, Text Type: N, H10
[177653553]
This complaint is from a literature source. As reported in the literature publication entitled,? Early postmarket results with pulserider for treatment of wide-necked intracranial aneurysms: a multicenter experience? (pmid:31703202). 1 patient with intracranial aneurysm who was treated with pulserider experienced intraprocedural aneurysm rupture leading to death. The complication resulted from the perforation of the left pca by the pulserider arch during deployment. Objective: traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. Pulserider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the pulserider device. Methods: this study was a prospective registry of patients treated with pulserider at 13 american neurointerventional centers following fda approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications. Cerenovus devices were used in this study. No device specific information (including catalog and lot number) were provided in the article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008680601-2020-00006 |
| MDR Report Key | 9666953 |
| Report Source | LITERATURE |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-04 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | PULSAR VASCULAR |
| Manufacturer Street | 130 KNOWLES DR SUITE E |
| Manufacturer City | LOS GATOS CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKPULSERIDER |
| Generic Name | INTRACRANIAL NEUROVASCULAR STENT |
| Product Code | NJE |
| Date Received | 2020-02-04 |
| Catalog Number | UNKPULSERIDER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSAR VASCULAR |
| Manufacturer Address | 130 KNOWLES DR SUITE E LOS GATOS CA 95032 US 95032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-04 |