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 Thrombus (2101); Vascular Dissection (3160)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

Date of publication journal article title: healing of femoral artery dissection after drug-coated balloon angioplasty: a case report with intravascular ultrasonography and angioscopy images sage open medical case reports volume 7: 1¿3 © the author(s) 2019 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/2050313x19834159 journals.Sagepub.Com/home/sco.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient presented with left leg intermittent claudication caused by atherosclerotic stenosis at left external iliac artery (eia) and middle of superficial femoral artery (sfa).Using intravascular ultrasonography (ivus) images, a 8.0¿40mm non-medtronic stent was deployed for eia lesion by contra-lateral approach.Dcb was chosen for treatment of 2cm lesion in the patient¿s (sfa).After preparation using 4.0¿ 40mm non-medtronic balloon, angioplasty using dcb (5.0¿40mm in.Pact admiral; medtronic, usa) was carried out at nominal pressure for 5min and resulted in 50% residual stenosis with linear dissection.Provisional stenting was not done because decent ante-grade blood flow allowed 10 extra minutes.Medication involved ongoing use of aspirin 100mg and rivaroxaban 15mg.Angiography 3 months from index procedure showed eia and sfa patency and healing of intimal dissection at sfa lesion was estimated by ivus.In angioscopy findings, red thrombus was seen in dissection cavity, but no white granular materials were seen at dcb dilated segment.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8439867
• MDR Text Key: 139442853
• Report Number: 9612164-2019-00976
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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?: No
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/02/2019
• 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: 80 YR