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

Catalog Number AB35W05100135

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Physical Resistance/Sticking (4012)

Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was attempting to treat bilateral common iliac lesions.No embolic protection was used.Right common femoral access was attempted to place a non-mdt 6 fr 90cm sheath up and over the aortic bifurcation on.035¿ non-mdt guidewire.The patient had significant bilateral common iliac disease and resistance was met trying to advance the sheath.Attempts were made to dilate the iliacs with a 5mmx60mm non-mdt balloon using a non-medtronic inflation device and saline/contrast mixture.This balloon ruptured prior to maximum dilation.The physician then prepared a 5mmx100mm evercross balloon as per ifu and attempted to place it across both common iliacs.This device was inflated to 18atms however, it ruptured in the severely calcified right proximal common iliac artery lesion.The artery had little tortuosity and was 12mm in diameter.The lesion had resulted in 75% stenosis.Resistance was met when removing this balloon and when removed from the sheath it was noticed that there was balloon material missing from the balloon catheter.At this point the.035 wire was exchanged for an.014¿ x300cm nitrex wire and an intravascular ultrasound(ivus) catheter was used to visualize and isolate the retained balloon material.It was determined that it was all within a 25-30mm segment of the right common iliac artery.The physician notified the patient of the situation and presented him with treatment options.It was decided to place bilateral common iliac covered 10mmx37mm kissing non-mdt covered stents to trap the retained balloon material.This covered the material completely.Ivus was repeated to confirm full exclusion after stent placement.The patient had no immediate complications after the procedure.

Manufacturer Narrative

Additional information: the evercross balloon was straddling the aortic bifurcation(in right and left common iliac artery at the same time) when the rupture occurred.Product analysis: the evercross dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.While still within the smaller zippered closure plastic pouch it was noted that the dilatation catheter balloon chamber exhibited radial and longitudinal tearing of the balloon chamber and that the distal radiopaque marker band was missing along with the evercross distal tip.The evercross dilatation catheter was received with sanguine residue within the inflation lumen of the y-manifold.The dilatation catheter was examined.The catheter exhibited twisting damage approximately from 3.5cm to 5cm from the distal tip of printed manifold strain relief.Approximately 33mm of balloon chamber material of the 100mm length balloon chamber was returned.The proximal balloon chamber radiopaque marker band was accounted for.The inner guidewire lumen within the balloon chamber exhibited tensile stretching.The inner guidewire lumen measured approximately 158mm in length.The distal end of the inner guidewire lumen exhibited tensile stretching and necking down.The inner guidewire lumen exhibited torsional and accordion damage, within the remaining portion of balloon chamber material.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: 7731081
• MDR Text Key: 115372580
• Report Number: 2183870-2018-00400
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684061473
• UDI-Public: 00821684061473
• 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,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Catalogue Number: AB35W05100135
• Device Lot Number: A511872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 105