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 Perforation (2001); Vascular Dissection (3160); Embolism/Embolus (4438); Restenosis (4576)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

Title: clinical outcomes of atherectomy plus drug-coated balloon versus drug-coated balloon alone in the treatment of femoropopliteal artery disease author: jung-joon cha, jae-hwan lee, young-guk ko journal: korean circulation journal year: 2021 vol/issue: 52:e1 ref: doi: 10.4070/kcj.2021.0246.Age or date of birth: average age.Sex: majority gender.Date of event: 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

A journal article was submitted detailing a study which investigated the outcomes of atherectomy plus dcb (a+dcb) compared with dcb alone for the treatment of femoropopliteal artery disease.In the a+dcb group, two types of atherectomy devices were used, directional devices (59.8%) and rotational devices (40.2%).Embolization protection filters were used in 65.9% of the a+dcb group.311 patients (348 limbs) were included in the study.Of these, 82 limbs were treated with a+dcb and 266 limbs with dcb alone.Medtronic¿s spiderfx and in.Pact admiral devices were used during the study.The in.Pact admiral dcb was used in approximately 70% of cases.In lesions requiring more than one dcb, a minimal overlap of 10 mm was obtained.If residual stenosis exceeded 30%, post-dilation was performed with an additional uncoated non-compliant balloon.Stenting was considered only as a last resort in the presence of flow-limiting dissection or when residual stenosis exceeded 30% despite post-dilation.Technical success is reported in 80.15% of the a+dcb group and 69.2% in the dcb alone group.Procedural related minor complications of arterial dissection, distal embolization, and vascular perforation are reported.Patients were clinically followed for a mean duration of 24.8±14.3 months.The 2-year primary clinical patency did not differ significantly between the a+dcb and the dcb group.Similarly, 2-year tlr-free survival was also not different between the two groups.The rates of mortality and the male at 2years showed no difference between the two groups.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: 13150178
• MDR Text Key: 283164658
• Report Number: 9612164-2022-00007
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

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: 12/15/2021
• Initial Date FDA Received: 01/04/2022
• 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: 70 YR
• Patient Sex: Male