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

Model Number	RONYX22530UX
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: device returned for evaluation.Two dislodged stents returned for analysis, 2.25 x 30 resolute onyx (pli 10) and 2.25 x 38mm resolute onyx (pli 20).Extensive deformation was evident to stents with struts severely stretched.Fracture points were evident to the stent wires.It was not possible to identify pli 10 or 20 due to the deformation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 2.25 x 30 resolute onyx rx coronary, drug eluting stent (pli10) was used to treat a severely calcified, mildly tortuosity lesion exhibiting 80% stenosis in the proximal right coronary artery (rca).There was no issues removing the device from the hoop.The device was inspected with no issues.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered.Excessive force was not used.An attempt was then made to deliver a 2.25 x 38 mm resolute onyx rx coronary, drug eluting stent (pli20) through a proximal 2.25 x 30 resolute onyx rx coronary, drug eluting stent (pli10) to a distal lesion the stent could not pass the proximal stent.There was no damage noted to the packaging of the 2.25 x 38mm device (pli20).The 2.25 x 38mm device was inspected with no issues, negative prep was not performed.It was reported that the 2.25 x 38 resolute stent (pli 20) deformed inside the 2.25 x 30 resolute onyx rx stent (pli 10).During removal of the 2.25 x 38mm deformed stent (pli20) it caught on the 2.25 x 30mm stent (pli10) and the 2.25 x 30mm stent (pli10) dislodged.Both stents were snared in the aorta and removed.The lesion was then treated with a 2.0 x 22 and 2.25 x 38 resolute onyx rx coronary, drug eluting stent.The patient is alive with no injury.

• 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: 9646340
• Report Number: 9612164-2020-00478
• Device Sequence Number: 319356
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/17/2020

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: 05/01/2020
• Device Model Number: RONYX22530UX
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0009123119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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: 68 YR