MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB35W08060080

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

Patient Problems Fistula (1862); Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient is a former smoker with a medical history of hypertension, diabetes, renal insufficiency and carotid artery disease.During the index procedure one evercross 8mmx60mm balloon was used with an inpact admiral dcb to treat the swing point of the left arm ((b)(6) 2017).Approximately 2 months post index procedure the patient suffered from excessive bleeding from fistula post dialysis ((b)(6) 2018).The event was described as avf stenosis and repair.Fistulogram corrected the issue.A fistulogram was performed and the swing point was treated with a non-mdt pta.The patient recovered.Approximately 6 months post procedure ((b)(6) 2018), patient suffered left avf bleeding and was treated with coumadin, two sutures, surgical intervention and revascularization of the swing point with non-medtronic pta ((b)(6) 2018).Approximately 11 months post procedure ((b)(6) 2018), patient suffered malfunction of the left upper extremity fistula, the patient was treated with revascularization of the venous outflow with non-medtronic pta ((b)(6) 2018).

Manufacturer Narrative

The cec adjudicated the revascularisation as target lesion, clinically driven and related to the device but not related to the procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8477179
• MDR Text Key: 140742444
• Report Number: 2183870-2019-00154
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684062074
• UDI-Public: 00821684062074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: AB35W08060080
• Device Lot Number: A488577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR