MAUDE Adverse Event Report: MEDTRONIC, INC ZUMA Z2 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number RONYX35008X

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

Patient Problem Myocardial Infarction (1969)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure five resolute onyx des were implanted, four were implanted in the lad and one in the cx.Cec adjudicated non-q-wave mi (target vessel-lad) 3rd udmi peri-pci the same day and commented there were new anterolateral ecg changes consistent with mi, large troponin and lad dissection.Cec also adjudicated there was no stent thrombosis.

Manufacturer Narrative

Lot number of pli 40 received.- lot of zuma guide catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Lot number of pli40 confirmed - resolute onyx stent.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZUMA Z2 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8612349
• MDR Text Key: 145127541
• Report Number: 9612164-2019-01755
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2019
• Device Catalogue Number: RONYX35008X
• Device Lot Number: 0008700648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Date Device Manufactured: 07/06/2017
• 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 Age: 86 YR
• Patient Weight: 58