MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME OTW; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNK-CV-GWY-SBI

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

Patient Problems Death (1802); Pneumothorax (2012)

Event Date 10/01/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the index procedure, one medtronic standard pta was used to treat the left venous outflow.Approximately 13 months post procedure, the patient expired.

Manufacturer Narrative

Patient has a medical history of diabetes and renal insufficiency.During the index procedure one admiral xtreme pta was used.Approximately 6 months post procedure the patient suffered pneumothorax which led to death.Investigator and sponsor assessed the pneumothorax event as not related to the device, procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the cec adjudicated the death as not related to the device, procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME OTW
• 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 ; 091708734
• MDR Report Key: 8454989
• MDR Text Key: 139951359
• Report Number: 9612164-2019-01052
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173515
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: UNK-CV-GWY-SBI
• Device Lot Number: 213636745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Date Device Manufactured: 07/13/2017
• 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
• Patient Age: 65 YR