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

Catalog Number UNKENTERPRISE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aneurysm (1708); Ischemia Stroke (4418)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device was received for analysis at the time of submission of the initial 3500a.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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by a published literature article, ¿results of endovascular therapy for vertebral artery fusiform aneurysm of non-posterior inferior cerebellar artery involved type¿ a (b)(6) man with an incidental right posterior inferior cerebellar artery and distal vertebral artery fusiform aneurysm which slowly progressed in 8 years underwent a stent assisted coil embolization with the enterprise vrd (unknown product code/ unknown lot #) stent.The stent was implanted by jailing technique and coil embolization started.However, some of the coils migrated into the stent.In this case, a postoperative diffusion weighted image displayed small high signal lesions identified in the right ventral lower pons.Three years later, the aneurysm enlarged again on the peripheral side of the embolized aneurysm.The patient is being closely followed up.The product is not available for the investigation.There is no additional information available.Model and catalog number are not available, but the suspected device is enterprise vrd stent.Other cnv devices that were also used in this study: none.Non-cnv webster devices that were also used in this study: unknown brand of coils.Publication details: title: results of endovascular therapy for vertebral artery fusiform aneurysm of non-posterior inferior carebellar artery involved type.Objective: trapping or neck bridge stent placement technique to preserve the parent artery has been performed as a treatment strategy for fusiform vertebral aneurysm.However, there is a concern that brain stem infarction will occur due to occlusion of the vertebral perforators.Tin this study, the treatment course of 17 cases in 3 years were retrospectively reviewed.Methods: 17 cases of fusiform vertebral aneurysm managed by an operator from 2015 were recorded, of which seven were ruptured and nine were unruptured aneurysms and one aneurysm was retreated after the first session because of recanalization.In ruptured cases, the entire aneurysm was treated with trapping.While in seven cases of unruptured aneurysm, stents were placed to preserve the parent artery and coil embolization was performed.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12102917
• MDR Text Key: 270049684
• Report Number: 1226348-2021-00041
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR