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

Catalog Number	ADM05004008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/14/2019
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
During the index procedure two inpact admiral balloon catheters were used to treat the distal sfa and popliteal artery of the right limb (r-1).Approx 11 months post index procedure the patient suffered right sfa restenosis.The patient was treated with pta of the target lesion.The patient recovered.The investigator assessed the event as possibly related to the index device and not related to the index procedure or paclitaxel.Safety assessed the event as possibly related to the index device and not related to the index procedure or paclitaxel.
Additional Manufacturer Narrative
Additional information: the event was not treated with pci.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The event is unresolved.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: 8669731
• Report Number: 9612164-2019-02173
• Device Sequence Number: 13972027
• Product Code: ONU
• UDI-Device Identifier: 00643169383555
• UDI-Public: 00643169383555
• 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): 08/28/2019

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: 10/03/2020
• Device Catalogue Number: ADM05004008P
• Device Lot Number: 0008820057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 08/09/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 08/07/2019; 08/28/2019
• 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: 70 YR
• Patient Weight: 48