MAUDE Adverse Event Report: CORDIS CASHEL UNKSAVVY435; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNK-PTA CATHETERS

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969)

Event Date 05/01/2001

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 and the catalog and lot numbers are not available.Qureshi a., i.(2001).Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement.Neurosurgery, vol.48, no.5.As reported in the literature by qureshi a., i.(2001).Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement.Neurosurgery, vol.48, no.5.; an angioplasty was performed with a 4.5 savvy poststent balloon and a postoperative minor stroke occurred and within 24 hours a postoperative non-q wave myocardial infarction that was asymptomatic occurred in patient 4.The patient developed ischemic deficits 4 hours after the procedure was completed.His nihss score of 21 at 24 hours improved to a score of 1 at 7 days after the procedure was performed.A non-cordis stent was placed.The patients maximum activated coagulation time was 244.An unknown sheath was removed after nine hours, then mechanical compression was used.The patient remained in the hospital for seven days.The device was not returned for analysis.A review of the manufacturing documentation associated with precise lot number presented no issues during the manufacturing process that can be related to the reported complaint.The sterile lot number of the savvy device was not provided; therefore, no review of manufacturing documentation could be performed.Given the limited information provided, the reported event ¿stroke and non-q wave myocardial infarction¿ 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.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.Myocardial infarction is a known potential adverse event associated with any invasive procedure in which medical devices/products are inserted into the patient¿s vasculature and manipulated to varying degrees and is listed in the ifu as such.Myocardial infarction (mi) or acute myocardial infarction (ami), commonly known as a heart attack is the interruption of blood supply to part of the heart, causing some heart cells to die.This is most commonly due to occlusion (blockage) of a coronary artery following the rupture of a vulnerable atherosclerotic plaque, which is an unstable collection of lipids (fatty acids) and white blood cells (especially macrophages) in the wall of an artery.There is no medical evidence to suggest a causal relationship between the stent implanted in the carotid artery and the reported mi.The inherent risk of the procedure combined with the patient¿s complex medical status, vessel characteristics and procedural factors may have contributed to the event.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.This report is related to the following reports: 9616099-2019-02732.9616099-2019-02734.

Event Description

As reported in the literature by qureshi a., i.(2001).Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement.Neurosurgery, vol.48, no.5.; an angioplasty was performed with a 4.5 savvy poststent balloon and a postoperative minor stroke occurred and within 24 hours a postoperative non-q wave myocardial infarction that was asymptomatic occurred in patient 4.The patient developed ischemic deficits 4 hours after the procedure was completed.His nihss score of 21 at 24 hours improved to a score of 1 at 7 days after the procedure was performed.A non-cordis stent was placed.The patients maximum activated coagulation time was 244.An unknown sheath was removed after nine hours, then mechanical compression was used.The patient remained in the hospital for seven days.

Manufacturer Narrative

Correction being submitted for updated product code, therefore the following sections d1,d2, g7, and h2 have been updated accordingly.

• Brand Name: UNKSAVVY435
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8351776
• MDR Text Key: 136591975
• Report Number: 9616099-2019-02736
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-PTA CATHETERS
• Device Catalogue Number: UNK-PTA CATHETERS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-CORDIS 8X40 STENT; NON-CORDIS VASCULAR CLOSURE DEVICE