MAUDE Adverse Event Report: MEDTRONIC VASCULAR GALWAY RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number UNK-CV-GWY-RONYX

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx rx coronary, drug eluting stent was used to treat a lesion.It was reported that a type 1 stent fracture was noted post stent implantation.There is no patient injury reported.

Manufacturer Narrative

A resolute onyx rx coronary, drug eluting stent was used to treat a none/mild tortuous and a none/mild calcified lesion exhibiting 90% stenosis.The main lesion was predilated.It was subsequently reported by core lab that the event did not qualify as stent fracture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC VASCULAR GALWAY; galway
• Manufacturer (Section G): MEDTRONIC VASCULAR GALWAY; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8906113
• MDR Text Key: 154764414
• Report Number: 9612164-2019-03464
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-RONYX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• 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 Age: 80 YR
• Patient Weight: 68