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

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

Patient Problems Reocclusion (1985); Pain (1994); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Majority age and gender. Event date is literature article published date journal: ann vasc surg 2018; 48: 79¿88. If information is provided in the future, a supplemental report will be issued.

Event Description

Purpose: the purpose of the study was to present a new alternative balloon catheter option for autogenous arteriovenous fistula (avf) dysfunction with a stiff constriction resistant to conventional balloon angioplasty. Event: a medtronic admiral xtreme balloon was expanded at the stenosis site with a pressure buildup to its working pressure. The balloon catheter could not be fully expanded at the site of stenosis, as manifested by a ¿¿thin-waist¿¿ (residual stenosis) sign. Then, the balloon continued to be dilated to its preset burst pressure. At this time, most patients complained of severe wrist pain, and a visual analog scale (vas) was supplied for each patient on which they marked the point that represented their perception of their current state. The stenosis was too difficult to successfully widen and subsequent angiography showed evidence of >30% residual stenosis; therefore, the treatment standard was not met. A vascutrak balloon was used to complete the procedure. At follow up, reoccurrence of occlusion and restenosis were reported. Re intervention was performed for these cases in the form of - surgical excision, reconstruction of a new fistula and recanalization. One case of a brachial artery pseudoaneurysm complication occurred in the perioperative period. Conclusion: the use of vascutrak balloon catheter to treat autogenous avf dysfunction resistant to conventional balloon angioplasty appears to be safe and effective, although further, large randomized controlled trials are necessary.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7585927
• MDR Text Key: 110572801
• Report Number: 9612164-2018-01378
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: CH
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,LITERATURE

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/11/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/11/2018
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/11/2018 Patient Sequence Number: 1