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

Catalog Number AB35W09040080

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

Patient Problems Death (1802); Perforation (2001)

Event Date 05/29/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The patient in this incident had a total right proximal to mid iliac occlusion that was approached retrograde on the right side.The vessel was pre-dilated.The target lesion was a cto (chronic total occlusion-100%) with severe calcification.The vessel was moderately tortuous.A viance catheter was initially used to try and cross the lesion but went sub-intimal and potentially outside the vessel in this attempt below the occlusion.A guide wire and re-entry catheter were used successfully to eventually navigate past the lesion and re-enter the iliac.Treatment to the proximal right iliac then was originally approached with the thought in mind of using a protégé gps on the ostial and proximal iliac with the goal of not compromising or jailing the internal iliac.A 10x80 protégé gps was deployed successfully.An everflex 8x80 was used to treat a stenosis on the left iliac successfully as well.It was then noted the patient¿s bladder looked compressed, a typical sign of an internal bleeding situation.A non-mdt covered stent was placed distal to the 10x 80 protégé in the right illiac where the bleed appeared to be and this seemed to resolve the issue.Upon further examination of the proximal right protégé gps stent, there was some angiographic haziness in the stent and the decision was made to post dilate the stent.The post dilatation was done with a 9x40 evercross.After post dilatation, the angiographic image showed a massive perforation at the stent level.A 10x38 non-mdt stent was placed in the 10mm protégé stent and additional 9x 38 or 9x58 non -mdt stent were deployed distal to the 10x38 stent.Angiographically, the perforation seemed to be resolved.There was no difficulty with deploying the protégé stents or removing the delivery systems.The patient left the cath lab and was put into icu.Later in i cu the patient had to be intubated and then had to go to the or for surgery.The patient later died the next day.This patient had many additional issues that were not elaborated.No cause of death nor autopsy report is available.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7640849
• MDR Text Key: 112413182
• Report Number: 2183870-2018-00356
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684062159
• UDI-Public: 00821684062159
• 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: Physician
• Type of Report: Initial
• Report Date: 06/27/2018

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 Expiration Date: 02/12/2021
• Device Catalogue Number: AB35W09040080
• Device Lot Number: A597028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/27/2018
• Date Device Manufactured: 02/13/2018
• 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