MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AMPHIRION; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Title: the medical and endovascular treatment of pad: a review of the guidelines and pivotal clinical trials journal: current problems in cardiology year: 2020.Date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports multiple studies in which in.Pact amphirion was used for the treatment of infrapopliteal disease.The single center debate-btk trial randomized 132 diabetic patients with rc >=4 cli to the in.Pact amphirion dcb or standard pta.The mean length of dcb-treated segments was relatively long at 129 +- 83 mm.Restenosis at 1 year was 27% in the dcb group vs 74% in the standard pta group (p <(><<)> 0.001).Tlr was 18% in the dcb group vs 43% in the pta group (p = 0.002).The infrapopliteal drug-eluting angioplasty versus stenting single-center trial randomized 50 patients with rc 3 to 6 cli due to infrapopliteal disease to treatment with 1 of 3 des or a paclitaxel dcb (in.Pact amphirion).The stents used were a zotarolimus des (resolute, medtronic, brescia, italy), a sirolimus des (cypher, cordis, bridgewater, new jersey), or an everolimus des (promus, boston scientific, natick, ma) depending on availability.6-month angiographic binary restenosis was lower in the des group (28% vs 57.9%; p = 0.0457).There were no differences in the incidence of tlr or major amputation.The adverse events reported from are deaths, cardiovascular accident and occlusion.

Manufacturer Narrative

Inpact amphirion is similar to inpact admiral - no malfunction occurred, only adverse events.The initial report was in correctly reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT AMPHIRION
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10143402
• MDR Text Key: 195224778
• Report Number: 9612164-2020-02186
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization