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

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

Patient Problems Inflammation (1932); Embolism/Embolus (4438)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Title: diffuse cutaneous manifestations after drug-coated balloon angioplasty authors: winsor chen, ashton lee, joseph sabat journal: annals of vascular surgery year: 2020 vol/issue: 69 ref: 10.1016/j.Avsg.2020.06.034.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a case of an uncommon cutaneous manifestation after paclitaxel-coated balloon angioplasty.Medtronic¿s in.Pact admiral drug coated balloon and evercross pta balloons were used during an elective endovascular intervention f ollowing preintervention angiogram which confirmed high-grade stenosis at the proximal anastomosis.Following pre-dilation pta was performed using an in.Pact admiral dcb resulting in satisfactory angiographic outcome without evidence of microembolization.A high-grade stenosis noted in the profunda femoris was treated with an evercross pta balloon.The procedure was completed successfully.One week later the patient presented with painful papules and macules on the left foot.Some lesions were erythematous with blister like appearance, whereas others were flat, consistent with petechiae.They were scattered along the plantar surface of foot and toes.Doppler examination revealed pedal signals and improved abi.Given distribution and timing of presentation, these lesions were deduced to be embolic phenomena related to the intervention to the bypass, which had direct in-line flow to the tibial vessels.Cutaneous manifestation, it is more likely that the cutaneous lesions were due to embolization of paclitaxel several days after intervention.Subject was treated conservatively with pain control and steroid medications.At 1-month follow-up, the lesions had largely healed and at 3 months follow-up, lesions had completely resolved and the patient remained free of claudication symptoms.

Manufacturer Narrative

Additional information: the corresponding author informed via email that the drug i the dug coated balloon is likely the cause of the cutaneous lesions.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 ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11164691
• MDR Text Key: 226638988
• Report Number: 9612164-2021-00164
• 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: 01/19/2021

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: 01/04/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR