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

Catalog Number	AB35W08060080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Stenosis (2263); Patient Problem/Medical Problem (2688)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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).
Additional 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8477179
• Report Number: 2183870-2019-00154
• Device Sequence Number: 11188618
• Product Code: LIT
• UDI-Device Identifier: 00821684062074
• UDI-Public: 00821684062074
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: AB35W08060080
• Device Lot Number: A488577
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR