MAUDE Adverse Event Report: INVATEC SPA PACIFIC PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombus (2101)

Event Date 11/25/2017

Event Type  Injury  

Manufacturer Narrative

Published date viabahn stent for hemodialysis shunt: efficacy, long segment recanalization and prognostic factors for reintervention the journal of vascular access 2018, vol.19(1) 76¿83 © the author(s) 2017 reprints and permissions: sagepub.Co.Uk/journalspermissions.Nav doi: 10.5301/jva.5000823 journals.Sagepub.Com/home/jva.If information is provided in the future, a supplemental report will be issued.

Event Description

The study evaluated the heparin bioactive surface (hbs) non-medtronic device efficacy in the maintenance or re-establishment of hemodialysis.Outcomes were stent patency intended as primary circuit patency (pp), assisted primary patency (app), target lesion primary patency (tlpp) and secondary patency (sp).Once the lesion had been crossed, pre-dilatation with 2- or 3-mm diameter balloon catheter (pacific plus, medtronic, (b)(4)) was subsequently performed to allow the passage of the delivery system.If the obstruction segment was crossed by 0.014¿ guidewire, it was replaced by 0.018¿ guidewire.The 4 fr short introducer sheath was then changed for a short introducer sheath with profile ranged from 6 fr to 8 fr, depending on stent diameter that was selected according to the diameter of the adjacent normal reference vessel.If the lesion could not be crossed, a second retrograde access was required through the puncture of the venous outflow, slightly more proximal to the obstruction.It is reported that 37 patients underwent 50 stent graft placement.Repeat procedures were required in cases where hemodialysis access dysfunction was identified with a total of 88 repeat procedures being undertaken.Three complications occurred: minor complications included two access hematoma that were conservatively managed with no consequences on hemodialysis circuit.A single case of infection of avg by staphylococcus aureus occurred three months after the stent placement.One procedure was unsuccessful because the circuit thrombosis occurred two days after the stent placement and the hemodialysis access was abandoned.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta 7; roncadelle (bs) 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta 7; roncadelle (bs) 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8051406
• MDR Text Key: 126546944
• Report Number: 3004066202-2018-00053
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• 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): Required Intervention
• Patient Age: 71 YR