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

Catalog Number	RONYX27526UX
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Deformation (2976)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101); Patient Problem/Medical Problem (2688)
Date of Event	04/06/2018
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
Previously two resolute onyx rx drug eluting stents were used to treat a moderately tortuous, severely calcified lesion in the proximal left anterior descending artery (lad).It was reported that the lesion was extremely calcified.Haziness was observed post implantation.There was no damage noted to the device packaging.There were no issues removing the devices from the hoop.The devices were inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The devices passed through a previously deployed stent.Resistance was encountered when advancing the devices and excessive force was used.It is reported that the patient presented less than two weeks post stent placement with possible thrombus or obstruction between the two implanted resolute onyx stents.It was indicated that the stents were overlapping at implant.At follow up, tissue prolapse was observed between the two stents.A concern was expressed that the stent may have fractured at the point of overlap.There was a question as to the patients compliance to dapt.It is believed the patient may have stopped taking it and that the tissue prolapse observed may have been thrombus.A non-medtronic stent was implanted to treat the 'gap' observed between the stents.Patient status is alive with no injury.
Additional Manufacturer Narrative
Cine image review: the images capture the two previously deployed resolute onyx stents in the lad.A thrombus as reported by the account is visible within the two implanted resolute onyx stents.The next images capture post-dilation of the stents with unidentified balloon devices.The reported fracture cannot be confirmed from the images, however a distortion between the overlap of the two stents was evident.An unidentified stent is then deployed within the previously deployed stents.The final images captured the vessel after stent implantation, with a better profile of the stent evident.The overlap between the two deployed stents is still visible within the vessel.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: 7532532
• Report Number: 9612164-2018-01179
• Device Sequence Number: 134517
• Product Code: NIQ
• UDI-Device Identifier: 00643169556928
• UDI-Public: 00643169556928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/10/2018

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: 10/10/2019
• Device Catalogue Number: RONYX27526UX
• Device Lot Number: 0008829933
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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 Weight: 55