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 Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969)

Event Date 03/01/2017

Event Type  Death  

Manufacturer Narrative

Year only valid.Svs/vqi registry summary reporting exemption approval number ¿ e2017023.

Event Description

Patient treated with a 5 x 40 in.Pact admiral balloon during the index procedure.The target lesion in the right popliteal artery was treated for occlusive disease.The lesion had moderate claudication and severe calcification.Lesion was pre-dilated.No complications during procedure and upon discharge.Patient expired 9 days later the death was documented as not related to the procedure.Cause of death is unknown.

Manufacturer Narrative

Additional information received reported that the patient was admitted to an outside hospital 2 days post procedure with chest pain and shortness of breath.A cardiac catheterization procedure was performed 5 days post index procedure.The patient experienced nausea and intense headache post procedure.A neurological exam revealed a right preponderant gaze and paucity of movements on the left side.Code bat (brain attack team) was called.Patient was dnr/dri.The cause of death was mi, cardiopulmonary arrest, and intracranial hemorrhage.The in.Pact admiral balloon diameter and length are known, however the catheter length is unknown.The possible device model numbers are adm05004008p or adm05004013p.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: 6838705
• MDR Text Key: 84370253
• Report Number: 9612164-2017-01207
• 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,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 12/19/2019
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 102