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

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

Patient Problems Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 06/03/2021

Event Type  Injury  

Event Description

A journal article was submitted detailing a study which compared long-term outcomes in patients with chronic limb-threatening ischemia (clti) treated with and without paclitaxel (ptx).A retrospective review was conducted of patients with clti treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination.Medtronic¿s in.Pact admiral drug coated balloon was amongst the ptx devices used in the cohort.Within the ptx group there were 574 patients included, with interventions as follow: pta alone 300, pta stenting 121, pta atherectomy 128, and pta stenting atherectomy 25.Mortality is reported as 31.4% in the ptx group as compared with 49.4% in the non-ptx group.Amputation is reported as 10.3% in the ptx group as compared with 18.1% in the non-ptx group.Amputation-free survival (afs) is reported as 36.7% in the ptx group as compared with 25.4% in the non-ptx group.The authors conclude revascularization with a paclitaxel coated device was associated with reduced all-cause mortality and major amputation compared with uncoated devices.Rates of target vessel revascularization were also lower in the paclitaxel treated patients.This study shows that treatment using a paclitaxel device may be especially beneficial in those presenting with chronic lim b-threatening ischemia.There is no established or suspected causal relationship between the device(s) and the death events.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Title: paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia author: norman h.Kumins, alexander h.King, ravi n.Ambani journal: clinical research study vascular laboratory year: 2021 vol/issue: 74(5) ref: doi: 10.1016/j.Jvs.2021.05.035.A2: average age a3: majority gender b3: 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.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 ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12850745
• MDR Text Key: 285344535
• Report Number: 9612164-2021-04501
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male