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

Catalog Number UNKNOWN

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

Patient Problems Embolism (1829); Hemorrhage, Cerebral (1889); Thrombosis (2100)

Event Date 01/01/2000

Event Type  Injury  

Manufacturer Narrative

As noted in a literature publication by ¿ishi, a.Et al., (2000).Carotid stenting with the use of wallstent.Interventional neuroradiology 6 (suppl1): 181-185;¿ one patient had a minor stroke with agnosia after the final angiography of the procedure.Heparin should have been given intravenously but was actually given subcutaneously.It was thought that the inadequate heparinization caused thrombosis and the distal embolism.The activated clotting time (act) was <200 seconds even though 5000 units of heparin was given.The procedure was a carotid artery stent case and a 3.5-millimeters (mm) savvy balloon was used to dilate lesions one or two times for predilatation.The device was not returned for evaluation.Without a lot number available, the device history record (dhr) review for the device was unable to be conducted.Stroke/cerebrovascular accident (cva) 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 an ischemic stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.80% of all strokes are ischemic.During ischemic stroke, diminished blood flow initiates a series of events (called ischemic cascade) that may result in additional, delayed damage to brain cells.Early medical intervention can halt this process and reduce the risk for irreversible complications.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.As it was noted, inadequate heparinization caused the thrombosis and distal embolism experienced by the patient.There is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.Ishii, a., mitsudo, k., kikuta, k., arakawa, y., hojo, m., goto, y.,.Yamagata, s.(2000).Carotid stenting with the use of wallstent.Interventional neuroradiology, 6(1_suppl), 181-185.Doi:10.1177/15910199000060s128.This article was found during a recent clinical evaluation review/literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The devices are savvy but the catalog and lot numbers are not available.

Event Description

As noted in a literature publication by ¿ishi, a.Et al., (2000).Carotid stenting with the use of wallstent.Interventional neuroradiology 6 (suppl1): 181-185;¿ one patient had a minor stroke with agnosia after the final angiography of the procedure.Heparin should have been given intravenously but was actually given subcutaneously.It was thought that the inadequate heparinization caused thrombosis and the distal embolism.The activated clotting time (act) was <200 seconds even though 5000 units of heparin was given.The procedure was a carotid artery stent case and a 3.5-millimeters (mm) savvy balloon was used to dilate lesions one or two times for predilatation.

• 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: 8348038
• MDR Text Key: 136489207
• Report Number: 9616099-2019-02724
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability