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

Catalog Number RONYX40012X

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a patent ductus arteriosus (pda) stenting procedure, one resolute onyx rx coronary drug eluting stent was implanted to treat a non-calcified lesion located in the proximal left pulmonary artery.The patient had a large ventricular septal defect (vsd) with pulmonary atresia and duct dependent pulmonary circulation.The device was inspected with no issues noted.The stent was deployed at 10 am.The lesion was post dilated using a non-medtronic balloon.Post procedural angiogram, echo and x-ray showed good stent position and bilateral lung flow.During a follow up appointment one month post procedure, it was reported that the stent was found to be broken in two pieces.It was stated that the distal end of the stent migrated into the distal right pulmonary artery (rpa).It was stated that the stent fracture appears to be distal to the area which was dilated.The detached portion of the device remains in the patient.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: the lesion was non-tortuous the ductus arteriosus measured about 3.7mm at its origin with some narrowing at pulmonary artery end.The ductus arteriosus was short and straight, measuring 11mm.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.No significant resistance was noted while advancing the stent.Excessive force was not used.Correction: device code (b)(4) added.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: a stent was deployed in the pulmonary artery with no issues encountered.From the images received, it appears that a wire has been inserted through the cells of the stent.Stent gapping has occurred.The reported fracture was not captured in the images received.Product analysis:image of the x-ray chest pa (postero-anterior) view in paediatric patient was reviewed.Cardiomegaly with congenital heart defects were observed.Two opaque artefacts are visible in the upper thoracic region.The first artefact is observable in the level of 4th intercostal space and probably represents the primary position and longitudinal projection of the stent implant in the ductus arteriosus.Distal end of this artefact is rough and edgy.The second artefact is observable in the level of the upper part of the 5th intercostal space, near right side of the sternum.This artefact probably represents the stent in transversal projection, in the distal end of the right pulmonary artery (rpa).From the x-ray image provided, the fracture and migration of the stent can be confirmed.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: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9957313
• MDR Text Key: 187950875
• Report Number: 9612164-2020-01558
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Catalogue Number: RONYX40012X
• Device Lot Number: 0009076872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 3