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

Catalog Number UNKENTERPRISE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 12/31/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (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.Cerenovus manufacturer's report number: 1226348-2021-00058 is related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent endovascular treatment for basilar artery trunk aneurysm and suffered thrombosis which spontaneously resolved.Model and catalog number are not available, but the suspected device is enterprise stent other cnv devices that were also used in this study: envoy, prowler 14 mc, non-cnv devices that were also used in this study: excelsior sl-10 microcatheter, neuroform stent, solitaire ab stent, hyperglide, perclose publication details: title: saccular or dissecting aneurysms involving the basilar trunk: endovascular treatment and clinical outcome objective: : basilar artery trunk aneurysms (btas) are a rare pathology and difficult to treat.We present our experience regarding angiographic results and clinical outcomes for 16 btas treated by reconstructive endovascular treatment (evt) using stent or balloon.Methods: between january 2003 and december 2014, 15 patients (mean age, 58.6 years; 11 males) with 16 btas were enrolled.Clinical manifestation, outcomes and procedural complications were evaluated retrospectively, and follow-up angiography was performed 12 and 24 months after procedure.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 12502828
• MDR Text Key: 282033333
• Report Number: 1226348-2021-00057
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVOY; EXCELSIOR SL-10 MICROCATHETE; HYPERGLIDE; NEUROFORM STENT; PERCLOSE; PROWLER 14 MC; SOLITAIRE AB STENT
• Patient Outcome(s): Other
• Patient Age: 59 YR