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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

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 sv 0.018 guidewire 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 4x20 savvy pre-stent balloon and intraoperative and postoperative hypotension requiring dopamine for 16h and intraoperative bradycardia occurred in patient 7.A non-cordis 8x20 stent was placed, and a non-cordis vascular closure device (vcd) was used.The patient¿s total hospital stay was one day.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 ¿hypotension and bradycardia¿ 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.Hypotension and bradycardia are well-known potential adverse events associated with the carotid stent implantation procedure.The hemodynamic instability that occurs both during and after carotid stent implantation is influence by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds, and distal protection devices, initiating a reflex via the glossopharyngeal nerve.This results in a fall in blood pressure and bradycardia.Stent placement may promote persistent stimulation of these baro-receptors.These reactions are anticipated relatively short-term adverse events.There is no evidence that the event was related to a manufacturing issue, therefore, no corrective action will be taken.Without a lot number to conduct a device history record (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 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 4x20 savvy pre-stent balloon and intraoperative and postoperative hypotension requiring dopamine for 16h and intraoperative bradycardia occurred in patient 7.A non-cordis 8x20 stent was placed, and a non-cordis vascular closure device (vcd) was used.The patient¿s total hospital stay was one day.

Manufacturer Narrative

Correction sent due to updated product code, therefore, the following sections d1, d2, g7, h1 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: 8351525
• MDR Text Key: 136594808
• Report Number: 9616099-2019-02734
• 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