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

Model Number ADM06004013P

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

Patient Problem Pneumonia (2011)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During index procedure, two in.Pact admiral paclitaxel eluting balloon catheters were used to treat the right mid sfa.Approximately one month post procedure, patient suffered scleroderma interstitial pneumonia and was treated with medication.Patient died three months later (non-cardiac death).Investigator and sponsor assessed event is unlikely related to the device, procedure or paclitaxel.

Manufacturer Narrative

Additional information: correct lot number provided for pli20.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
• MDR Report Key: 8068380
• MDR Text Key: 127056166
• Report Number: 9612164-2018-03184
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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
• Device Expiration Date: 10/18/2020
• Device Model Number: ADM06004013P
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0008843062
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 51