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

Model Number H1-LX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Embolism (1829); Occlusion (1984)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during procedure to use hawkone lx and spider fx, using ultrasound guidance and a seldinger technique, the right common femoral artery was accessed with a micropuncture kit and upsized to a 5fr sheath over a wire.Ultrasound was used to confirm vessel patency, localized needle into the luminal vessel, and for safety purposes a picture was saved for the medical record.An omniflush catheter was taken to the perirenal aorta and a co2 aortogram was performed.The omniflush catheter was brought to the aortic bifurcation and a pelvic angiogram was performed.The omni flush catheter was advanced in an up-and-over fashion over the aortic bifurcation and a left lower extremity selective angiogram was performed.The sheath was upsized over the wire to a 7fr sheath.A stiff straight glidewire and glide catheter were used to attempt to traverse the chronic total occlusion from above.This was unsuccessful to re-enter the true lumen as there was a blind segment just above the reconstitution that ended in the collateral.Given this, retrograde access was obtained via fluoroscopic guidance and access to the p1 segment of the popliteal artery with a spinal needle and non-medtronic wire in the typical fashion.Catheter was then inserted into the p2 segment of the popliteal artery and using the non-medtronic wire, the occlusion was crossed from below and through-and-through access was obtained.The lesion was predilated with a 3 mm balloon.A glide catheter was advanced to the p3 segment of the popliteal artery and a 7 mm spider filter was deployed.A 7fr hawk one lx device was used to atherectomize the entire left sfa.A post-dilatation with a 5 mm balloon was performed.Angiographic result was suboptimal with multiple areas of dissection and vessel recoil.It was decided to proceed with placement of a non-medtronic drug-eluting stent, now that the calcified plaque had been debulked.The stents were two 7mm x 120mm and one 7mm x 100mm drug-eluting stents.These were then post dilated with a 6 mm balloon.The filter was captured, and a completion angiogram was performed.There was evidence of distal embolization in the common plantar artery.At this point, a glide catheter and glidewire were advanced down to the posterior tibial artery.This was exchanged for a pt2 wire.Nitroglycerin was infused.A primary percutaneous mechanical thrombectomy with a 7fr export device was performed and the embolic debris was removed.A completion angiogram revealed a successful percutaneous thrmboembolectomy.Runoff was unchanged from pre procedure.The catheters, wires and sheaths were brought back.The aortic bifurcation was evaluated.Given the stent grafts that were present in the left common iliac artery, there was infolding from going up-and-over.An ultrasound was used to gain access to the left common femoral artery and upsized to 6fr sheat over a wire.Both common iliac artery stents were angioplastied with an 8mm x 20mm balloon.Completion angiogram reveals widely patent stents with no evidence of stenosis or flow-limiting distortion in the stent.The left femoral puncture was closed with a 6fr angio-seal and the right femoral puncture was closed with an 8fr angio-seal.Distal pulses were intact.There were no complications.Patient was transferred to pacu in stable condition.

Manufacturer Narrative

Additional information.The lesion was located in the mid-superficial femoral artery and presented 70% stenosis.It was reported that the jaw/plunger on the hawk was unable to close and pack the nosecone after the first pass through thus making it ineffective at plaque removal.They were not able to flush the device or remove the plaque manually.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.

Manufacturer Narrative

Additional information: lot number provided.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.

Manufacturer Narrative

Additional information: the cutter was located inside the housing upon device removal from the patient.Product analysis: the device was returned to medtronic for evaluation.The cutter driver was not returned.There was no structural damage noted to the metal housing.Biological debris was noted within the housing.There was no dried blood noted within the cutter window.The cutter was located within the cutter window.There was no damage noted to the cutter.The device failed the minimum packing stroke acceptance criteria 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.

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.

• Brand Name: HAWKONE 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway MN
• MDR Report Key: 10110445
• MDR Text Key: 193668583
• Report Number: 2183870-2020-00157
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0009922800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention