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

Catalog Number	AB35W09060080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician performed a bilateral stenting procedure of both right and left common iliac arteries with unknown stents using ¿kissing¿ technique.It was reported that post stent deployment, the need for further angioplasty was identified in the right mid common iliac artery.The lesion was calcified and the artery had little tortuosity.An evercross 9mmx40mm pta balloon was used to perform the angioplasty procedure.The device was removed from its packaging and inspected with no issues noted.The device was prepped as per the ifu.No embolic protection was used.It was reported that this balloon burst on inflation without any incident.A second evercross 9mmx60mm pta balloon was selected for use.It was reported that a circumferential/ radial burst occurred during inflation for this balloon.It was noted that an inch of the tip was missing.This was confirmed by further imaging which demonstrated the broken piece still in situ.The physician had trouble in removing the fragments of the balloon from the artery.This broken tip couldn't be retrieved via snare.A surgical intervention under general anesthesia was required to remove fragments.The surgery was reported to be successful in removing the fragments.No apparent ill effects to the patient were reported.
Additional Manufacturer Narrative
Additional information received: the lesion length was approximately 4cm long, >90% stenosis and heavily calcified.The artery had an 8.3mm lumen on angiography.The procedure was bilateral stenting of the both iliac arteries which was successfully completed using a protege 9 x 60 mm stent.The procedure used a 6fr 11cm non-medtronic sheath and a amplatz extra stiff guidewire.A non-medtronic inflation device with half saline/half contrast was used.Each balloon burst occurred somewhere between rated and burst pressure.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: 6881802
• Report Number: 2183870-2017-00413
• Device Sequence Number: 16264418
• Product Code: LIT
• UDI-Device Identifier: 00821684062173
• UDI-Public: 00821684062173
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 07/26/2019
• Device Catalogue Number: AB35W09060080
• Device Lot Number: A316579
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 11/15/2017
• 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
• Patient Age: 69 YR