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

Catalog Number	ADM05012013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101)
Date of Event	08/09/2018
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
During index procedure, two in.Pact admiral paclitaxel eluting balloon catheters were used to treat the right mid sfa.Approximately one month post procedure, the patient suffered right sfa cto (acute occlusion).Revascularization of the target lesion was carried out 11 days later using a pta balloon catheter.Patient recovered.Investigator and sponsor assessed event is unlikely related to the device, procedure or paclitaxel.
Additional Manufacturer Narrative
The patient has a medical history of previous bare metal stenting of the iliac.Dissection occurred during pre-dilation and during the procedure, with no provisional stenting.Thrombosis of the target lesion was also recognized via imaging approximately one month post index procedure.Grafting was also carried out on the same day as the revascularization procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event date updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Event date updated.

• 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: 8089386
• Report Number: 9612164-2018-03279
• Device Sequence Number: 1459743
• Product Code: ONU
• UDI-Device Identifier: 00643169383630
• UDI-Public: 00643169383630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: ADM05012013P
• Device Lot Number: 0008837738
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 03/15/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 11/23/2018; 04/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 49