MAUDE Adverse Event Report: CORDIS CASHEL UNKSAVVY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNKSAVVY

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

Patient Problem Stroke/CVA (1770)

Event Date 03/01/2002

Event Type  Injury  

Manufacturer Narrative

This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history) are not available.The device is an unknown savvy balloon catheter and the catalog and lot numbers are not available.Criado, f.J., lingelbach, j.M., ledesma, d.F., & lucas, p.R.(2002).Carotid artery stenting in a vascular surgery practice.Journal of vascular surgery,35(3), 430-434.Doi:10.1067/mva.2002.121209.As reported in the literary article by criado, f.J., lingelbach, j.M., ledesma, d.F., & lucas, p.R.(2002).Carotid artery stenting in a vascular surgery practice.Journal of vascular surgery,35(3), 430-434.Doi:10.1067/mva.2002.121209; report one patient had a minor stroke that began intraprocedurally 2 minutes after post-balloon dilatation of the carotid stent with a 5x20-mm savvy balloon angioplasty catheter.The complication resulted in transient aphasia (lasting several hours) and monoparesis of the hand, which resolved after 2 weeks.Initially, during the cas, a 0.018-in sv-5 cordis small vessel guidewire was used to cross the ica lesion, which was then pre-dilated with a 4- by 40-mm savvy cordis balloon angioplasty catheter.Stenting involved placement of a self-expanding device from the ica across the bifurcation into the distal cca (across the origin of the eca).The indication for the cas was symptomatic (stroke, tia) ica stenoses.The patient had independent assessment by a neurologist before and after the cas.The device was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) reviews could not be performed.Given the limited information provided, the reported event ¿minor stroke¿ could not be confirmed and the exact root cause could not be determined.With the limited amount of information available and without return of the product for analysis or films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to the reported event.Stroke is a known potential risk associated with implanting a stent in a carotid artery and is listed in the ifu as such.It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure.The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process).The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion.This act, inherent to the procedure may have contributed to the reported event.A blood vessel that is not blocked, but is extremely narrowed, can also cause a stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.Early medical intervention can halt this process and reduce the risk for irreversible complications.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.

Event Description

As reported in the literary article by criado, f.J., lingelbach, j.M., ledesma, d.F., & lucas, p.R.(2002).Carotid artery stenting in a vascular surgery practice.Journal of vascular surgery,35(3), 430-434.Doi:10.1067/mva.2002.121209; report one patient had a minor stroke that began intraprocedurally 2 minutes after post-balloon dilatation of the carotid stent with a 5x20-mm savvy balloon angioplasty catheter.The complication resulted in transient aphasia (lasting several hours) and monoparesis of the hand, which resolved after 2 weeks.Initially, during the cas, a 0.018-in sv-5 cordis small vessel guidewire was used to cross the ica lesion, which was then pre-dilated with a 4- by 40-mm savvy cordis balloon angioplasty catheter.Stenting involved placement of a self-expanding device from the ica across the bifurcation into the distal cca (across the origin of the eca).The indication for the cas was symptomatic (stroke, tia) ica stenoses.The patient had independent assessment by a neurologist before and after the cas.

• Brand Name: UNKSAVVY
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8340639
• MDR Text Key: 136453796
• Report Number: 9616099-2019-02710
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

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: Health Professional
• Device Model Number: UNKSAVVY
• Device Catalogue Number: UNKSAVVY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1