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

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s pacific plus pta balloon catheter.Survey results received for an interventional cardiologist with 20 years¿ experience.The respondent has been using medtronic¿s pacific plus pta balloon catheter since (b)(6) 2019.Overall, the respondent has used medtronic¿s pacific plus pta balloon catheter in a total of 60 procedures since beginning to use the system all of which have been carried out within the past 12 months.Of these procedures, the devices were used for dilatation of stenoses in patients with obstructive disease in iliac arteries (10), femoral arteries (10), iliofemoral arteries (10), popliteal arteries (10), infrapopliteal arteries (10), renal arteries (5), and 5 during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The respondent has not used medtronic's pacific plus pta balloon catheter in any other anatomical locations other than those described above.The respondent reports complications death associated specifically with angiography.These events were deemed as being device related.The complications of death were considered as being very concerning.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10688556
• MDR Text Key: 211620511
• Report Number: 9612164-2020-03943
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: 10/09/2020
• 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