MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK ATK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	P4055
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/03/2019
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 used an silverhawk lxm to treat a fibrous/soft tissue lesion with moderate degree of tortuosity and calcification, presenting cto (chronic total occlusion -100%) in the left proximal superficial femoral artery (sfa).Artery diameter and lesion length were 6mm and 80 mm respectively.The device was inspected and prepared as per the ifu with no issues identified.Patient had a prior stent deployed in left sfa.The silverhawk was advanced through the left proximal sfa/ common femoral artery where multiple passes was performed.The device was removed and a 6x80 chocolate balloon was used f.The balloon was removed and angiogram was performed using a non-medtronic (navicross) catheter.The silverhawk lxm was re-advanced for additional passes.During the additional passes, it was reported that the device got stuck on the stent struts of the previously deployed stent in the left sfa.The silverhawk was turned off and multiple attempts to remove the silverhawk were performed with no success.A non-medtronic sheath (7x90 destinations terumo ) and a 3.5x30 sprinter balloon were used in attempt to remove the silverhawk from the patient's vasculature, unsuccessfully.Another angiogram was performed and no arterial bleeding was observed.The patient was transferred to a hospital and underwent an endarterectomy to remove device from left proximal sfa.The surgery went well and device was removed from the body.The patient is doing fine.
Additional Manufacturer Narrative
Additional information: a non-medtronic stent was previously deployed.The tip of the silverhawk did not detach in the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the customer proved 6 cine images associated to this reported event.All images have been reviewed.It is unknown if the order the cine images were provide aligns with the order of events during the procedure.Image #1 shows balloon is inflated within the vessel/target area.Image #2 shows the implanted stent identified with marker bands possibly from the pta device prior to or post inflation within the stent.Image #3 and #4 show the silverhawk cutter window of the distal assembly with the inner diameter of the implanted stent.It did not appear that the cutter was exposed within the stent.Image #5 and #6 show the cto which is likely the intended target area.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8964183
• Report Number: 9612164-2019-03758
• Device Sequence Number: 2610002
• Product Code: MCW
• UDI-Device Identifier: 00643169968431
• UDI-Public: 00643169968431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• 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): 11/20/2019

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: 02/19/2021
• Device Catalogue Number: P4055
• Device Lot Number: 0009603218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 11/15/2019; 11/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/12/2019; 11/18/2019; 11/20/2019
• 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: 73 YR
• Patient Weight: 57