MAUDE Adverse Event Report: COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	H1-LS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: the hawkone was not received for evaluation.Seven photographs of cine images and three movies of contrast flow were received for evaluation.The first cine image is of an atherectomy device in the targeted vessel anatomy, (mid superficial femoral artery).The date of the image was not provided but most likely is a procedural image.The second image is a ct scan image cross section of the targeted anatomy and includes two arrows with an annotation of 25mm.The reflective mass in the image between the arrows may be the aneurysm.The date of the image was not provided.The third image is of a contrast flow in the area of mid superficial femoral artery a reflective ¿tear drop¿ mass appears to encapsulate a catheter in the superficial femoral artery.The date of the image was taken was not provided.The fourth image is of a contrast flow through mid superficial femoral artery with calcified lesions in the vessel.The fifth image is of guidewire/catheter going from the left leg to the right leg with the tip of guidewire/catheter coiled in t he aorta.The sixth image is of a pta balloon device inflated in the mid superficial femoral artery on a guidewire.The images must be procedural images.The seventh image is of a guidewire through the mid superficial femoral artery.A dark ¿shadow¿ covers a portion of the artery.The artery shows an increase in the lumen internal profile.The date of the image was taken was not provided.The eighth and ninth images are from a video received dated approximately 2 years post procedure.The images are from a contrast flow study through the mid superficial femoral artery.A guidewire is visible within the artery.A dark ¿shadow¿ covers a portion of the artery.The date of the image was taken was not provided.The tenth image is from a video also dated approximately 2 years post procedure.The images are from a contrast flow study through the mid superficial femoral artery.A guidewire is visible within the artery.The walls of the artery appear to be rugged and not smooth at the top of the image.The vessel profile appears to be larger than expected.The date of the image was taken was not provided.The eleventh and twelfth images are from a video dated approx imately 2 years post procedure.The images are from a contrast flow study through a lower section of the mid superficial femoral artery.A guidewire is visible within the artery.The walls of the artery appear to be smooth at the top of the image.The vessel profile appears to be nominal.The date of the image was taken was not provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A hawkone device was used to treat a 20mm calcified lesion in the patients¿ mid superficial femoral artery (sfa) of diameter 7mm.Lesion exhibited 80% stenosis.Slight vessel tortuosity and severe vessel calcification reported.Pre-dilation was not performed.No issues reported during use of the device.Four passes were completed, and it is reported the artery diameter had increased larger than baseline.Angioplasty was performed using an inpact admiral dcb and patient was discharged from hospital.Routine follow-up has shown the common femoral continuing to increase.Almost 2 years post-procedure, the vessel is reported to now be approximately 2.5 cm in diameter.Patient is reported to have aneurysm of common femoral artery.The hawkone is suspected to have been a contributor to the event.Patient was referred to vascular surgeon.
Additional Manufacturer Narrative
Additional information: patient had original treatment on the right mid common femoral artery.Image review: the hawkone was not returned for evaluation.Seven photographs of cine images and three movies of contrast flow were received for evaluation.The first cine image is of an atherectomy device in the targeted vessel anatomy, (mid superficial femoral artery).The second image is a ct scan image cross section of the targeted anatomy and includes two arrows with an annotation of 25mm.The reflective mass in the image between the arrows maybe the aneurysm.The third image is of a contrast flow in the area of mid superficial femoral artery a reflective ¿tear drop¿ mass appears to encapsulate a catheter in the superficial femoral artery.The fourth image is of a contrast flow through mid superficial femoral artery with calcified lesions in the vessel.The fifth image is of guide wire or catheter going from the left leg to the right leg with the tip of guide wire or catheter coiled in the aorta.The sixth image is of a pta balloon device inflated in the mid superficial femoral artery on a guide wire.The seventh image is of a guide wire through the mid superficial femoral artery.A dark ¿shadow¿ covers a portion of the artery.The artery shows an increase in the lumen internal profile.The eighth and ninth images are from video received.The images are of a contrast flow study through the mid superficial femoral artery.A guide wire is visible within the artery.A dark ¿shadow¿ covers a portion of the artery.The tenth image is from video received.The images are of a contrast flow study through the mid superficial femoral artery.A guide wire is visible within the artery.The walls of the artery appear to be rugged and not smooth at the top of the image.The vessel profile appears to be larger than expected.The eleventh and twelfth images are from video received.The images are of a contrast flow study through a lower section of the mid superficial femoral artery.A guide wire is visible within the artery.The walls of the artery appear to be smooth at the top of the image.The vessel profile appears to be nominal.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: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9896689
• Report Number: 2029214-2020-00306
• Device Sequence Number: 14062905
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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
• Report Date (Section B): 04/21/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2019
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: A247552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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: Other
• Patient Age: 70 YR