MAUDE Adverse Event Report: MEDTRONIC IRELAND PACIFIC PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNK-CV-GWY-PCP

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

Patient Problem Death (1802)

Event Date 11/23/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

During a revascularization, an in.Pact deb paclitaxel balloon catheter was used to treat the target lesion (prox and mid sfa).During a second revascularization, two pacific plus balloon catheters were used to treat non-target lesions (distal sfa and pop1).Same day, a pacific plus balloon catheter was also used to treat the target lesion.During a third revascularization, an in.Pact pacific paclitaxel eluting balloon catheter was used to treat the target lesion.During a fourth revascularization, an amphirion deep was used to treat a non-target lesion.Approximately 19 months post first revascularization, 10 months post second revascularization, 7 months post third revascularization and 2 weeks post fourth revascularization, patient suffered hypoxia which was treated with medication.Patient died later on the same day.Investigator assessed event is not related to the index device, procedure or paclitaxel.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 7590425
• MDR Text Key: 110699616
• Report Number: 9612164-2018-01400
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/12/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-PCP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/12/2018
• 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): Death
• Patient Age: 83 YR
• Patient Weight: 58