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

Catalog Number RONYX30030X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

One resolute onyx coronary drug eluting stent was attempted to be used to treat a lesion in the proximal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated and thrombus aspirated.It was reported that during inflation contrast was seen in the distal lad, indicating a balloon rupture, and the stent was partially opened in the proximal segment.It was decided to re-dilate with another balloon but when withdrawing the balloon the entire stent came out along with it.The stent was managed to be retrieved out of the left main and brought to the right iliac artery, where it was then removed with a snare.It was stated that there was no choice but to cut the hub.The procedure was completed using a non-medtronic stent.No further patient injury reported.

Manufacturer Narrative

Additional information: the device was prepped per ifu with no issues noted.The balloon rupture occurred on the first inflation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: the device returned with a detachment on the hypotube 7.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Multiple kinks were evident on the hypotube.A full dislodgement of the stent did not occur.The stent was positioned on the balloon, but was bunched and damaged, and displaced over the distal end of the balloon and delivery system.The distal stent was positioned over the distal markerband.Stent wraps were raised, bunched and overlapping.Crimp impressions visible on the balloon surface.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.The device returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the proximal end of the balloon.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a pin-home burst evident on the proximal working length of the balloon.The balloon material protruding outwards.No other deformation was evident to the remainder of the device.Correction: b1 updated to adverse event product problem.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11990377
• MDR Text Key: 255910447
• Report Number: 9612164-2021-02283
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: RONYX30030X
• Device Lot Number: 0010526547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 07/06/2021; 07/16/2021
• Supplement Dates FDA Received: 07/16/2021; 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR