MAUDE Adverse Event Report: MEDTRONIC IRELAND AMPHIRION DEEP PTA BALLOON CATHETER; CATHETER, PERCUTANEOUS

Catalog Number UNK-CV-GWY-AMPH

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

Patient Problem Stenosis (2263)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During revascularisation of the target lesion, an amphirion deep pta and an in.Pact pacific paclitaxel eluting balloon catheter were used.During a second revascularization of the target lesion, an admiral xtreme pta and an in.Pact pacific paclitaxel eluting balloon catheter were used.During a third revascularization of the target lesion, an amphirion deep pta and two in.Pact pacific paclitaxel eluting balloon catheters were used.Approximately 20 months post first revascularization, 17 months post second revascularization and 13 months post third revascularization, patient suffered in-stent restenosis of the left sfa and popliteal (target lesion) and was treated with revascularization.A drug eluting balloon catheter was used during treatment.Patient recovered.

Manufacturer Narrative

The in-stent restenosis of the left sfa and popliteal was treated with a in.Pact pacific drug coated balloon approximately 4 days post the event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AMPHIRION DEEP PTA BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7518195
• MDR Text Key: 108379328
• Report Number: 9612164-2018-01103
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052791
• 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
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-AMPH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 86