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

Catalog Number RONYX35030X

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician used two resolute onyx drug eluting stent devices (ronyx35030x and ronyx40012x) to treat a lesion in the proximal circ umflex artery and lad.There was no damage noted to the devices packaging.The lesion was pre-dilated.There were no issues noted when removing the devices from the hoop/tray.The devices were inspected with no issues.Negative prep was not performed.The first stent (ronyx35030x) did not pass through a previously deployed stent.No resistance was encountered when advancing the device and excessive force was not used.The first stent (ronyx35030x) was successfully deployed.An attempt was then made to insert the second stent.Resistance was encountered when advancing the second stent (ronyx40012x), excessive force was not used.It is reported that when the second stent (ronyx40012x) was being advanced, interaction occurred with the first stent (ronyx35030x) and the ronyx40012x stent dislodged from the delivery system.While attempting to retrieve the dislodged ronyx40012x removal difficulties were encountered, resulting in the dislodgement of the ronyx35030x device.Multiple wire method was used in an attempt to retrieve the dislodged ronyx40012x, however the deployed ronyx35030x was pulled out as well.No patient injury is reported.

Manufacturer Narrative

Product analysis: the stent was returned off the balloon, the delivery system was not returned for analysis.The two stents were returned attached to each other and attached to two guidewires.The stents and guidewires were returned loaded in non-mdt guide catheter.A y-port connector, was also returned with stents.Blood tissue was visible along the stent during initial inspection.Stent was placed in waterbath to disperse blood tissue.Visual analysis of stent was performed, and deformation was evident to the complete stent, with wraps and struts appearing stretched.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cine image review: the returned images capture the severely stenosis diagonal branch of the lcx and lad.The images capture the pre-dilation and successful stent implantation of the 3.5 x 30 mm resolute onyx stent.Post dilation is performed on the 3.5 x30 stent.The image does not capture the attempted delivery of the 4.0x12mm stent, however an image captures the dislodged 4.0x12mm stent located immediately distal to the guide catheter tip and immediately proximal to the implanted 3.5x30mm onyx stent.The dislodged 4.0x12 stent is then removed with a wire, the previously implanted 3.5x30 mm stent is also removed attached to the dislodged stent.The procedure continued with successful stent implantation, with improved flow evident post procedure.The returned photograph captures the reported dislodged 4.0x12mm stent with the stretched 3.5x30mm migrated stent attached.The stents are still on the guidewire post removal from the patient.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: 7224097
• MDR Text Key: 98411677
• Report Number: 9612164-2018-00153
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Catalogue Number: RONYX35030X
• Device Lot Number: 0008729373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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