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

Catalog Number	ADM05015008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2019
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 in.Pact admiral dcb were used to treat the left prox, mid and distal sfa.During a revascularisation procedure, the patient was treated with an inpact admiral dcb.Approximately 11 months post procedure the patient suffered critical limb ischemia reported as probably related to the target lesion and was treated with a pta the same day.The event is resolved.The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel.
Additional Manufacturer Narrative
Additional information: approximately 11 months post index procedure and 3 months post revascularization, the proximal and mid left sfa were also treated with an inpact admiral dcb.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the revascularization procedure took place 12 days post event.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: 8939881
• Report Number: 9612164-2019-03625
• Device Sequence Number: 2099142
• Product Code: ONU
• UDI-Device Identifier: 00643169576322
• UDI-Public: 00643169576322
• 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): 11/18/2019

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: 09/20/2020
• Device Catalogue Number: ADM05015008P
• Device Lot Number: 0008805284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 11/11/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/18/2019
• 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: 74 YR
• Patient Weight: 35