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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vascular Dissection (3160); Restenosis (4576)
Event Date 02/04/2023
Event Type  Injury  
Manufacturer Narrative
A2: average age a3: majority sex literature ref: 10.1016/j.Avsg.2023.01.043 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.
 
Event Description
Medtronic received a literature article titled 'drug-coated balloons vs.Drug-eluting stents for treatment of long femoropopliteal lesions'.282 consecutive patients (177 dcb and 105 des) satisfied the enrolment criteria.After propensity score stratification, 228 patients (139 men; median age 69 years) were included in the study:131 patients who were treated with dcb and 97 with des.In the dcb group, in.Pact admiral and in.Pact pacific balloons were used exclusively.In the des group, patients were treated a non medtronic nitinol stent with a polymerfree paclitaxel coating.The choice of the dcb type (in.Pact pacific or in.Pact admiral), access site (contralateral vs.Antegrade), and predilation with an undersized, uncoated balloon was left to the discretion of the operator.In the dcb cohort 100 (76.3%) of the 131 lesions were predilated, and provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flowlimiting dissection (13, 9.9%), and other reasons (6, 4.6%).The binary restenosis rates were 23.9% (26/109) in the dcb; the clinically driven tlr rates were 15.6% (17/109) vs.Any tlr 19.0% (15/79,).There was no procedure related mortality in either cohort.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key17918987
MDR Text Key325455961
Report Number9612164-2023-04615
Device Sequence Number1
Product Code ONU
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P140010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other
Type of Report Initial
Report Date 10/12/2023
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 09/12/2023
Initial Date FDA Received10/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexMale
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