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

Catalog Number	AB35W05150135
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Codes	Occlusion (1984); Patient Problem/Medical Problem (2688)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use an evercross pta balloon to treat a severely calcified, slightly tortuous lesion, with 80% stenosis, in the mid distal left superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 6mm & 130mm, respectively.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped with no issues identified.A 6fr non-medtronic sheath and a 0.035 non-medtronic guidewire were used with no embolic protection.The device was inflated with a non-medtronic inflation device to 8atm.The device did pass through a previously deployed stent and no resistance was encountered nor excessive force used on advancing the device to the target lesion.The evercross balloon ruptured on first inflation.Difficulties were experienced in removing the balloon so the patient was transferred to surgery for a femoral bypass as the vessel was occluded due to the device rupture.
Additional Manufacturer Narrative
Additional information: the evercross pta balloon was used for post-dilation following successful implant of an everflex entrust.The evercross balloon was removed from the stent and then reinserted in the deployed stent (deflated) to use for a wire exchange.The balloon became stuck after wire exchange, inflation was attempted resulting in balloon rupture.All fragments of the evercross were removed the patient¿s vessel.Patient is doing well post-surgery.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the customer provided two photos of the evercross catheter post-procedure.Both photos are of the same device, but at different angles.The first photo provided focused on the balloon segment of the evercross catheter.It appears the balloon is filled with red biologics and is condensed/compressed in a distal direction.The photo of the balloon in its current state is consistent with a radial fracture of the balloon.The photo also shows a fractured everflex entrust stent.The stent struts were closed around the exterior of the evercross balloon.The portions of the stent which stretched out from the balloon showed fractured ends of the stent struts.The second photo, at a different angle, shows the distal and proximal end of the evercross catheter segment.The photo shows a loaded gray guidewire.The entire evercross catheter was not included the photo.The catheter shaft was likely cut or fractured proximal to the balloon segment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8477362
• Report Number: 2183870-2019-00155
• Device Sequence Number: 16398619
• Product Code: LIT
• UDI-Device Identifier: 00821684061527
• UDI-Public: 00821684061527
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2020
• Device Catalogue Number: AB35W05150135
• Device Lot Number: A472922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 07/15/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/03/2019; 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention