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

Catalog Number	RONYX25026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and calcified lesion exhibiting 20% stenosis located in the ostium circumflex (cx) artery-obtuse marginal (om).The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the stent and excessive force was used during delivery.It was reported that while attempting to deliver the resolute onyx stent through the circumflex artery to get to the obtuse marginal that the resolute onyx stent became caught on a strut of a stent previously implanted in the circumflex artery.Force was used to push the resolute onyx stent through the previously implanted stent but the onyx could not pass.The resolute onyx stent was pulled back and it was noted that stent dislodgement had occurred.An attempt was made to advance the delivery balloon back into the dislodged stent but failed.Different types of balloons were attempted to remove the dislodged stent but failed.Three or four different snares were attempted to remove the dislodged stent but also failed.It was indicated that while attempting to snare that the stent could not be unstuck and became elongated in the aorta.The lesion was further treated by doing more pre-dilations.The patient was reported to be alive with no further injury.
Additional Manufacturer Narrative
Additional information: the brand of the previously implanted stent is unknown.No damage was noted to the previously implanted stent.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: a kink was evident on the hypotube.The stent was not present on the balloon and did not return for analysis.The balloon folds were expanded.Crystallized contrast was visible in the balloon.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was no other damage evident to the remainder of the delivery system.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8623358
• Report Number: 9612164-2019-01831
• Device Sequence Number: 16645494
• Product Code: NIQ
• UDI-Device Identifier: 00643169556836
• UDI-Public: 00643169556836
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2020
• Device Catalogue Number: RONYX25026UX
• Device Lot Number: 0009379544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 07/05/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/26/2019; 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 106