MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISEENC

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.No device was received for analysis at this time.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.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿spontaneous delayed proximal migration of enterprise stent after staged treatment of wide necked basilar aneurysm: technical case report ¿ a (b)(6) year-old female patient with a large unruptured wide- necked basilar aneurysm and small unruptured right superior cerebellar and left anterior cerebral artery aneurysms underwent a two-stage enterprise stent assisted coil-embolization has experience stent migration.The stent has migrated proximally with all 4 distal tines of the stent within the neck of the aneurysm, and the proximal tines nearing the vertebral basilar junction.The decision was made to proceed with coil embolization as the stent position appeared to be in the ¿waffle cone¿ configuration.The aneurysm was then catheterized with a prowler-14 microcatheter (cordis neurovascular, inc.) over a synchro 2 soft guidewire.After this, cordis orbit coils (cordis neurovascular, inc.) were deployed into the aneurysm.The coil loops approached the left and right pca origins; however, excellent flow remained in these vessels.The aneurysm demonstrated no evidence of extravasation, and there was no evidence of distal branch occlusion on follow- up angiographic images.However, there was remaining flow in the aneurysm in the most dependent portion of the dome region.No additional coils were placed because of the thrombotic event.The intravenous reopro infusion was maintained overnight.The patient was then awakened from the general anesthetic and had no evidence of iatrogenic neurological deficit.Aim of this study: to demonstrate a unique technical issue with a relatively newly released intravascular stent used for adjunctive treatment of wide- necked cerebral aneurysms.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8228886
• MDR Text Key: 132508852
• Report Number: 1226348-2019-00818
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR