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

Catalog Number RONYX35018X

Device Problems Device Dislodged or Dislocated (2923); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the physician was attempting to use a resolute onyx drug eluting stent to treat a severely calcified and severely tortuous proximal cx lesion exhibiting 90% stenosis.It was reported that the device was removed from its packaging as per ifu and inspected with no issues noted.No difficulties note when removing the protective sheath.The stent was inspected post removal and no problem noted.Negative prep was not performed.The lesion was pre-dilated.The device remained on neutral pressure during delivery of the device.The device passed through a previously deployed stent.Resistance was encountered during attempted delivery and excessive force was used.It was reported that following failed delivery and during removal, the stent dislodged during withdrawal of the device in the guide catheter.A micro catheter terumo finecross was in the guide catheter launcher.The device blocked in the micro cath and the dislodgement occurred.The physician decided to remove the guide catheter containing the dislodged stent.¿please note that this device (resolute onyx) is not marketed in the united states; however, it is similar to the united states marketed device (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.¿.

Manufacturer Narrative

Evaluation summary: the stent was returned off the delivery system.The delivery system catheter was not returned.A number of the stent sinusoidal wraps (segments) were deformed at one end of the stent.The remaining wraps were intact.

Manufacturer Narrative

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: 5731775
• MDR Text Key: 47592116
• Report Number: 9612164-2016-00599
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110013
• 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: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2018
• Device Catalogue Number: RONYX35018X
• Device Lot Number: 0007950733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2016
• 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: 70 YR
• Patient Weight: 90