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

Model Number	AB35W06200135
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/11/2020
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
Physician intended to use an evercross pta balloon with a 6fr non-medtronic sheath and non-medtronic 0.035 guidewire during treatment of a 250mm cto (chronic total occlusion-100%) in the patient¿s mid left superficial femoral artery (sfa).Vessel diameter reported as 6mm.Severe vessel calcification is reported.No damage noted to the product packaging prior to sue.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.A non-medtronic inflation device as used with 50/50 contrast and saline mix.The device was advanced through the 6fr sheath from contralateral access site over the non-medtronic 0.035 wire to the target left sfa lesion.No resistance was encountered during advancement.The balloon was inflated once to dilate the lesion and was removed.A stent was then placed in the left sfa.The evercross was again advanced to post-dilate the stent.It is reported that the balloon ruptured on second inflation at a pressure of 8atm.Following the rupture, the balloon was removed from the patient.The physician then attempted to remove the detached fragments using a snare unsuccessfully.The patient was then transferred to a local hospital.It is reported fragments of the balloon remain in the patient¿s left sfa.No further injury reported.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it is unknown if vessel damage occurred.Current patient health status is unknown.It is unknown if the fragments were eventually removed from the patient or if any other treatment was required.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the evercross dilatation catheter was received within a tyvek pouch, within a nested series of sealed plastic pouches, within a knotted tied close plastic shop pouch, within its opened labeled shelf carton, and loosely coiled within its opened labeled pouch.No ancillary devices nor procedural images were received for evaluation.The evercross catheter was received with the balloon chamber exhibiting a radial tear.Not all of the components were returned.Missing was distal balloon chamber material, distal bond, inner guidewire lumen, distal radiopaque marker band, and distal tip.Per the initial reported event description ¿fragments of the balloon remain in the patient¿s left sfa¿.The inner guidewire lumen terminates at the distal edge of the proximal radiopaque marker band.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 10166777
• Report Number: 2183870-2020-00178
• Device Sequence Number: 2152430
• Product Code: LIT
• UDI-Device Identifier: 00763000184513
• UDI-Public: 00763000184513
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/01/2020

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: 04/24/2023
• Device Model Number: AB35W06200135
• Device Catalogue Number: AB35W06200135
• Device Lot Number: B014503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 07/02/2020; 09/30/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/25/2020; 07/06/2020; 10/01/2020
• 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