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 Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Renal Failure (2041); Urinary Tract Infection (2120); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Title: outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease author: ochoa chaar, cassius iyad; kim, tanner i.; kiwan, gathe journal: journal of vascular surgery year: 2020.Ref: doi.Org/10.1016/j.Jvs.2020.08.146.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.The following causes of death were listed within the pcd group: cardiovascular, cancer, respiratory, gastrointestinal, infectious, other/unspecified.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 aims to further investigate the outcomes and causes of mortality for patients treated with paclitaxel coated devices (pcds) 366 patients were included in the study of which 138 were treated with a (pcd).Among those treated with pcds, 61 (44%) had received drug-coated balloons, 52 (38%) had received drug-eluting stents, 13 (9%) had received atherectomy and a drug-coated balloon, and 12 (9%) had received atherectomy and a drug-eluting stent.Medtronic¿s in.Pact admiral device was used.Perioperative outcomes within the pcd group include hematoma, bleeding, pseudoaneurysm, urinary tract infection, deep vein thrombosis, stroke, acute renal failure, return to operating room, major amputation.Long-term follow-ups (2.9 years +/- 1.9 years) within the pcd group included death, ipsilateral major amputation, and any ipsilateral reintervention.Causes of death w ithin the pcd group were stratified by group type.The following causes of death were listed within the pcd group: cardiovascular, cancer, respiratory, gastrointestinal, infectious, other/unspecified.The author concluded pcd use for treatment of femoropopliteal disease was not associated with increased mortality.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 ANGIOPLASTY CATHETER
• 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: 11059749
• MDR Text Key: 223611206
• Report Number: 9612164-2020-05034
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

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: 12/15/2020
• Initial Date FDA Received: 12/22/2020
• 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