MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB35W10040080

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

Patient Problems Death (1802); Perforation of Vessels (2135); Blood Loss (2597)

Event Date 09/25/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

The physician was attempting to use a protégé gps self-expanding stent to treat a moderately calcified lesion with 85% stenosis located in the right proximal mid distal common iliac artery. There was no degree of tortuosity and there were no abnormalities reported in relation to patient anatomy. The lesion was predilated using an 8 x 60 evercross pta balloon, prior to deployment of the stent. There was no damage noted to the packaging of the 8x60 balloon and there were not any issues noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues noted. A competitor¿s 7fr sheath and a 0. 035 guidewire was used during this procedure and embolic protection was not used. The device was inflated using a competitor¿s inflation device using inflation fluid. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. Excessive force was used during delivery. After pre-dilation, the protégé gps stent was successfully deployed in the target area. Embolic protection was not used. A 10x40 evercross pta balloon was used to post dilate the lesion after the stent was deployed. The device was prepped per the ifu with no issues no resistance was encountered when advancing the device. Excessive force was used during delivery. The device was inflated using a competitor¿s inflation device using the inflation fluid. The physician made multiple inflations with this balloon inside the stent and distal to the stent in the external iliac artery. It was reported that during this procedure, the patient started to get short of breath and compressions were started. The physician had perforated the right iliac artery with the 10x40 evercross pta balloon. After the artery was perforated, two surgeons were called in and inflated the 8x60 evercross balloon to occlude the bloodflow and prevent bleeding. The patient was taken from the outpatient lab and brought to the hospital for surgery. It was reported that the patient expired due to the complications. The physician stated that oversized balloon perforated the vessel, and that there is no allegation of product malfunction against the devices. The physician reported that the devices worked fine.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6978417
• MDR Text Key: 90285485
• Report Number: 2183870-2017-00464
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: AB35W10040080
• 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: 09/25/2017
• 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

Patient Treatment Data

Date Received: 10/25/2017 Patient Sequence Number: 1