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 Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	08/09/2019
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 a resolute onyx rx coronary drug eluting stent was used to treat a lesion.It was reported that the stent dislodged during delivery to the lesion.The stent was left in the internal iliac artery.There is no patient injury reported.
Additional Manufacturer Narrative
The lesion in the proximal circumflex was pre-dilated with a 2.5x12mm non-medtronic balloon.The stent delivery system was advanced to the lesion over the wire.The stent delivery system was taken out over the wire undeployed.The lesion was again dilated using a non medtronic balloon.The stent was again advanced to the lesion over the wire.The stent was unable to cross the lesion.The stent delivery system, wire and 6f non-medtronic guide extension catheter were pulled back into the 6f launcher guide catheter.The guide catheter was removed.A 6f non-medtronic guide catheter was inserted.It was reported that the stent came off the delivery system undeployed and travelled downstream to the left iliac artery.A spider fx filter wire was inserted to retrieve the stent.The stent was inside the filter basket.A wire was re-inserted to capture the basket/stent.The resolute onyx was loose in the spider when both devices were being retracted together.The exposed edge of the resolute onyx (within the spider) caught the proximal edge of the internal iliac and dislodged from the spider into the internal iliac.The undeployed stent was stationary in the left internal iliac.The stent was left in the internal iliac artery.The procedure was completed.The patient tolerated the procedure well.There is no patient injury reported.There were no issues with the spider device.The spider was removed fully intact and with no noticeable damage.The spider functioned fine and the product remained intact and its integrity was not compromised.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: 8887218
• Report Number: 9612164-2019-03364
• Device Sequence Number: 3079543
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: 00643169556898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 04/04/2021
• Device Catalogue Number: RONYX27515UX
• Device Lot Number: 0009681862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: 76 YR
• Patient Weight: 91