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 Hemorrhage, Cerebral (1889); Ischemia (1942)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

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.  this information was not provided in the reported event or available at the time of report submission.  this is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2019-00966.

Event Description

Event description: this complaint is from a literature source.As reported in the literature publication entitled, ¿microhemorrhagic transformation of ischemic lesions on t2*-weighted magnetic resonance imaging after pipeline embolization device treatment¿.4 patients with intracranial aneurysms, from the stent-mediated embolization group (en group), who underwent stent-assisted coil embolization developed ischemic lesions confirmed by dwi (diffusion-weighted mri) day post procedure and asymptomatic microbleeds in 6 months postprocedure.All microbleeds in were observed in the same infarcted area as that noted on dwi performed 1 day postprocedure, objective the authors sought to demonstrate that hemorrhagic transformation of ischemic lesions is the main cause of delayed intracerebral hemorrhage (ich) after pipeline embolization device (ped) treatment and to estimate the rate of hemorrhagic transformation of new postprocedure ischemic lesions.Methods patients who underwent ped placement (ped group) from november 2015 to march 2017 or stent-mediated embolization (en group) from december 2010 to october 2015 were retrospectively analyzed.Pre- and postprocedural mr images and 6-month follow-up mr images for each patient were scored for the presence of postprocedural bland ischemic and hemorrhagic lesions using diffusion-weighted mri (dwi) and t2*-weighted mri (t2*wi), respectively.

• 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
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8859981
• MDR Text Key: 153436648
• Report Number: 1226348-2019-00967
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2019
• 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 Outcome(s): Life Threatening
• Patient Age: 61 YR