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

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

Patient Problem Stenosis (2263)

Event Date 01/12/2018

Event Type  Injury  

Event Description

During the index procedure the left anastomosis was treated with reef pta balloon catheter.Approximately 5 months post index procedure, the laboratory results showed stenosis in the juxta anastomotic region.The patient was treated with a non-mdt pta in the anastomosis.The investigator assessed this event as not related to the index device, procedure but possibly related to the therapy.The event is resolved.

Manufacturer Narrative

The investigator reported that the event was not related to the therapy.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pta treatment approximately 5 months post index procedure was to treat restenosis of the anastomosis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: REEF
• 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: 7227032
• MDR Text Key: 98518026
• Report Number: 9612164-2018-00163
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092361
• 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,Followup,Followup,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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: 05/07/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR