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

Catalog Number	RONYX27515UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
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 moderate tortuosity, severely calcified lesion exhibiting 90% stenosis in the proximal circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated using 3 different size sprinter balloons.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.The first attempt to cross the proximal circumflex lesion with the resolute onyx stent failed.It was reported that during a second attempt to place the stent, the stent became caught on the edge of the entry port of the 6f telescope guide extension catheter (gec) and the stent came off the balloon.The stent dislodged proximally toward the stent delivery system catheter shaft while inside the guide catheter, proximal to the telescope entry port.At that time, the guide catheter was inside the patients body.The stent came off inside the patient, but not in the patients anatomy as it was still on the stent delivery system catheter shaft, and proximal to the telescope entry port.All devices were removed together.There appeared to be some scratches / indentations at the telescope entry port caused by the stent struts.The patient is alive with no injury.
Additional Manufacturer Narrative
The dislodged stent returned on a guidewire, with a telescope device.No delivery system was returned.Deformation was evident to the dislodged stent, with struts raised, bunched and overlapping.Lot number was confirmed based on the deformation to the device matching the event description.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: 8586761
• Report Number: 9612164-2019-01606
• Device Sequence Number: 2192224
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: 00643169556898
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: RONYX27515UX
• Device Lot Number: 0009351877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 36