MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number	ADM06015013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	09/24/2018
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
It was reported that during treatment of moderately calcified fibrous lesions with 80% stenosis in the distal mid left superficial femoral artery (artery diameter 6mm), physician first prepped two lesions in the right superficial femoral artery (sfa) with a hawkone directional atherectomy device and then post dilated with two in.Pact admiral balloons.Following post-dilation, a dissection was noted in the distal sfa and popliteal artery that was determined to require stenting.The physician then used an everflex entrust with a non-medtronic 7fr.55cm sheath and a spider fx 7mm embolic protection device.It was reported that stent deformation occurred in vivo during deployment.The physician decided to post dilate the stent over a wholey wire that was placed inside the stented segment.He post-dilated the stent with a non-medtronic 6x100 pta (percutaneous transluminal angioplasty) balloon.The patient is reported to be doing fine and the final angiogram showed a patent vessel with better runoff to the distal vessels.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7994383
• Report Number: 9612164-2018-02874
• Device Sequence Number: 19157939
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• 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
• Report Date (Section B): 10/23/2018

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: 05/17/2021
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0009146884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/23/2018
• 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: 61 YR
• Patient Weight: 97