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

Model Number	ADM07006013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/05/2018
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, a non-medtronic device was used to treat the venous outflow.Approximately 7 weeks later, revascularization of the anastomosis was carried out using an in.Pact admiral paclitaxel eluting balloon catheter.Approximately 6 weeks post revascularization, patient suffered recurrent avf stenosis with revascularization of the anastomosis carried out same day using an admiral xtreme pta balloon.Patient recovered.Investigator assessed event is not related to the study device, procedure or paclitaxel.Sponsor assessed event is not related to the device, procedure or paclitaxel.
Additional Manufacturer Narrative
Event date updated ((b)(6) 2018).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: in.Pact av access was used during revascularization.If information is provided in the future, a supplemental report will be issued.

• 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: 7817450
• Report Number: 9612164-2018-02176
• Device Sequence Number: 14037407
• Product Code: ONU
• UDI-Device Identifier: 00643169383357
• UDI-Public: 00643169383357
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup,Followup
• Report Date (Section B): 07/16/2020

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: 06/28/2019
• Device Model Number: ADM07006013P
• Device Catalogue Number: ADM07006013P
• Device Lot Number: 0008692138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 06/22/2020
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/24/2018; 07/16/2020
• 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: Required Intervention
• Patient Age: 68 YR