MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-04 for STENT - VASCULAR RECONSTRUCTION UNKENTERPRISEENC manufactured by Codman And Shurtleff, Inc.
[188230286]
Product complaint #: (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 the no lot number was provided by the customer. Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.? Information regarding patient weight, height, medical history, race, and ethnicity was not reported. Cerenovus manufacturer's report numbers: 1226348-2020-00019, 1226348-2020-00020, 1226348-2020-00021. Are related to the same incident.
Patient Sequence No: 1, Text Type: N, H10
[188230287]
This complaint is from a literature source. As reported in the literature publication entitled,? Outcome and prognostic factors of ruptured middle cerebral artery aneurysms treated via endovascular approach: a single-center 11-year experience? (pmid:31493611). 4 patients with ruptured middle cerebral artery (mca) aneurysms who underwent stent-assisted coiling experienced ischemic complication (side-branch occlusion). Objective: to investigate outcomes and prognostic factors of ruptured middle cerebral artery (mca) aneurysms, treated via endovascular approach, with improving treatment materials and techniques. Patients and methods: a total of 185 consecutive patients, admitted with acutely ruptured mca aneurysm sand treated by endovascular methods between 2006 and 2016, were retrospectively reviewed. Their baseline characteristics, procedure-related complications, and angio-graphic and clinical outcomes were collected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2020-00018 |
| MDR Report Key | 9787301 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-13 |
| Date of Event | 2016-12-31 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-04 |
| 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 | CODMAN AND SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENT - VASCULAR RECONSTRUCTION |
| Generic Name | INTRACRANIAL NEUROVASCULAR STENT |
| Product Code | NJE |
| Date Received | 2020-03-04 |
| Catalog Number | UNKENTERPRISEENC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |