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 Transient Ischemic Attack (2109)

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 sustained a single-episode transient ischemic attack (tia), characterized by means of motor/sensory deficit of the hand, occurring 2 hours after cas.He was treated with a 12-hour infusion of abciximab (reopro) and intravenous heparin.Recovery was complete (by the sixth hour), without sequelae or recurrences.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).Post-balloon dilatation of the stent involved the use of a 4.5- by 20-mm or 5- by 20-mm savvy balloon catheter.The indication for the cas was symptomatic (stroke, tia) ica stenoses.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 ¿transient ischemic attack (tia)¿ 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.Tia is a well-known potential adverse event associated with the carotid stent implantation procedure and is listed in the ifu as such.Tia is often associated with a temporary stoppage or slowing of blood flow to the cerebral arteries.The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may collect in the embolic protection device or flow downstream potentially disrupting perfusion both during and after carotid stent implantation.By definition ((b)(6)), the symptoms of a tia may last up to 24 hours, but they often last only a few minutes.Tia occurs when the blood supply to part of the brain is briefly interrupted.Tia symptoms are similar to those of stroke but do not last as long.Most symptoms of a tia disappear within an hour.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.Additionally, usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

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 sustained a single-episode transient ischemic attack (tia), characterized by means of motor/sensory deficit of the hand, occurring 2 hours after cas.He was treated with a 12-hour infusion of abciximab (reopro) and intravenous heparin.Recovery was complete (by the sixth hour), without sequelae or recurrences.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).Post-balloon dilatation of the stent involved the use of a 4.5- by 20-mm or 5- by 20-mm savvy balloon catheter.The indication for the cas was symptomatic (stroke, tia) ica stenoses.

• 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: 8333716
• MDR Text Key: 135994297
• Report Number: 1016427-2019-02510
• 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: 02/12/2019

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: 02/12/2019
• 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