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

Model Number	ADM05012008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/15/2020
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 the popliteal (r1) was treated with an in.Pact admiral pta.Approximately 23 months later revascularisation was carried out to treat restenosis of the target lesion, the popliteal.During the revasc, an in.Pact admiral pta was used and the patient was also treated with a des.
Additional Manufacturer Narrative
Additional information: the event was also treated with medication.Patient recovered.It is reported that event is possibly related to device, procedure and paclitaxel.A bare-metal stent was implanted and not a drug-eluting stent as previously reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: event date updated relevant history updated event also treated with hospitalization and medication.The patient recovered.The event was stated as possibly related to the target limb, lesion, vessel, disease under study and an underlying condition.The investigator assessed the event as possibly related to the target limb, paclitaxel and the device; and causally related to the procedure.The sponsor assessed the event as possibly related to the target limb, paclitaxel and the device, and causally related to the procedure.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: 10050627
• Report Number: 9612164-2020-01866
• Device Sequence Number: 2861919
• Product Code: ONU
• UDI-Device Identifier: 00643169383586
• UDI-Public: 00643169383586
• 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): 06/11/2020

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: 09/24/2020
• Device Model Number: ADM05012008P
• Device Catalogue Number: ADM05012008P
• Device Lot Number: 0008809264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 05/15/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 05/15/2020; 06/11/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 63