MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-07-080-120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
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 attempted to use a protege everflex to treat a 80mm calcified plaque lesion in the mid right common femoral artery.Artery diameter was 6mm.A 6fr sheath and a non medtronic 0.035 guidewire was used in the procedure.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped per ifu with no issues.The device had passed through a previously deployed stent but there was no resistance encountered during advancement or deployment of the device.It was reported that after stent deployment a fracture occurred in the middle of the stent.Some of the stent deployed correctly.Resistance was encountered when the stent catheter was removed to the hub of the sheath and it was verified by x-ray that a portion of the fractured stent remained in the sheath.The potion of the stent that remained in the sheath was removed manually in tandem with the sheath hub.The portion of the stent that was deployed in the vessel was ballooned with a 7x80 evercross with no issues.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: the protégé everflex stent was returned within a biohazard bag.The sds stent delivery system and ancillary devices were not returned for evaluation.Visual inspection of the returned stent revealed evidence of a fracture and stent elongation.A portion of the stent was detached.Per the product label specification, the stent is measured an 80mm stent.The returned stent was measured approximately 35mm, an indication approximately 45mm of the stent was detached.Image review three images received from customer.Per the images, a fractured and elongated stent was noted.Multiple stent struts were detached.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: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8549537
• Report Number: 2183870-2019-00184
• Device Sequence Number: 1744208
• Product Code: FGE
• UDI-Device Identifier: 00821684060094
• UDI-Public: 00821684060094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Catalogue Number: PRB35-07-080-120
• Device Lot Number: A609526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR