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

Catalog Number UNKENTERPRISEENC

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

Patient Problems Death (1802); Renal Failure (2041)

Event Date 01/31/2017

Event Type  Death  

Manufacturer Narrative

Product complaint #: (b)(4).Mfr site: codman and shurtleff, inc ((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. .

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿forward deployed coil embolization with multiple overlapping stents for ruptured blood blister-like aneurysms: technical considerations and outcomes¿.A (b)(6) female patient with blood blister¿like aneurysm (bba) who underwent stent assisted coil embolization dead from a complication of end-stage renal disease (esrd) on 3 weeks after treatment.Objective: describe a safe dense coil packing technique into and just proximal of bbas using a semi-jailing technique for the treatment of bbas of the internal carotid artery (ica) and report the long-term clinical outcomes.Seventeen patients, 7 men and 10 women, were treated by forward deployment of coils under multiple overlapping stenting from september 2008 through august 2017.Patients¿ ages ranged from 27 to 73 years (mean 47.9 ± 11 years).

Manufacturer Narrative

This is a correction of the previous submission report related to the literature article entitled ¿forward deployed coil embolization with multiple overlapping stents for ruptured blood blisterlike aneurysms: technical considerations and outcomes".The product code was updated from unkenterpriseenc to unkenterpriseenf.

• 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: 8782253
• MDR Text Key: 150762526
• Report Number: 1226348-2019-00949
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 48 YR