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

Catalog Number PCP050060130

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

Patient Problem Death (1802)

Event Date 01/20/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

During a revascularization procedure one medtronic standard pta was used to treat the anastomosis.During another revascularization procedure one medtronic standard pta was used to treat the in cannulation zone.Approx 10 months post first revascularization and three months post second revascularization, the patient suffered respiratory failure and died three days later.The investigator and safety assessed the event as not related to the index device, procedure or paclitaxel.

Manufacturer Narrative

The patient has a medical history of hypertension, hyperlipidemia, renal insufficiency, coronary heart disease and a previous peripheral revasc of the venous outflow.During the revasc to treat the anastomosis one pacific plus pta was used.During the revasc treat the in cannulation zone one inpact admiral pta was used.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated event is not related to procedure, therapy or device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC PLUS US
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8325274
• MDR Text Key: 135698545
• Report Number: 9612164-2019-00475
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2018
• Device Catalogue Number: PCP050060130
• Device Lot Number: 1G004905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 76 YR