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

Model Number RONYX25038JX

Device Problems Fracture (1260); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Stenosis (2263); Injury (2348)

Event Date 06/26/2019

Event Type  Injury  

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 mildly tortuous, severely calcified lesion exhibiting 90% stenosis located in the circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed without issue.It was indicated that restenosis occurred and a non-medtronic cutting balloon was used to treat the restenosis.It was indicated that while using the non-medtronic cutting balloon that a stent fracture occurred.The fractured piece of approximately 15mm was removed from the patient's body by being caught on the non-medtronic cutting balloon.The patient was reported to be alive with no further injury.

Manufacturer Narrative

Relevant history: the patient was a dialysis patient and had previously received bypass surgery on rca and lad.Additional information: the lesion was located in the prox to distal circumflex (cx) artery.It was reported that approx.12 months later restenosis occurred.Pre-dilation was performed with non-compliant balloon and non-medtronic cutting balloon.Thereafter, a drug-coated balloon (dcb) was used.Approx two months later, the previously reported restenosis occurred.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis summary: an image shows the distal section of a cutting balloon device.A section of a stent is visible attached to the distal tip of the cutting balloon device.The stent appears stretched an image shows the distal section of a cutting balloon device.A section of a stent is visible attached to the distal tip of the cutting balloon device.The stent appears have been fractured and stretched.An image shows portion of a stent on a gauze.The stent appears fractured and stretched.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 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: 8788645
• MDR Text Key: 150957888
• Report Number: 9612164-2019-02848
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: RONYX25038JX
• Device Catalogue Number: RONYX25038JX
• Device Lot Number: 0008882256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 09/19/2019
• Supplement Dates FDA Received: 08/21/2019; 10/04/2019
• Date Device Manufactured: 11/16/2017
• 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 Outcome(s): Required Intervention