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

Model Number RONYX22515UX

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Occlusion (1984); Injury (2348); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure, two resolute onyx rx coronary drug eluting stents were used to treat a moderately tortuous, moderately calcified lesion located in the left anterior descending (lad) artery and diagonal branch.The devices were inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the resolute onyx stent (lot 0009833921) dislodged during delivery in the lad while attempting to deliver the stent to the diagonal branch.It was stated that the stent flared and was jailed by another stent that was deployed across the diagonal branch.Another stent was used to crush the dislodged stent into the wall of the mid lad.It was also reported that the second resolute onyx stent (lot 0009983738) deformed in vivo during positioning.It was stated that the physician completed the procedure using another stent.The patient was reported to be alive with no further injury.

Manufacturer Narrative

Additional information: a 2.75x38mm resolute onyx was implanted in the mid cx.A 3.0x18mm resolute onyx was implanted in the proximal cx, overlapping the proximal section of the first stent.It was stated that there was further pinching of the om branch, the wire was pulled back and placed down the om branch.Ballooning was performed with a 1.5x15mm sprinter legend, but a stent was still unable to pass in the large om branch.It was stated that a 2.25x18 mm stent would not cross.A 2.0x20 sprinter legend device was used to balloon the ostial and proximal om branch, four times.A guideliner was then used.Another stent was unable to pass.It was stated that the stent dislodged as it got stuck on the metal that was in the ostial, proximal om branch.Further ballooning was performed with a 2.5x30 mm sprinter legend and a 2.0x38mm sprinter legend.A 2.25x15mm onyx was deployed in the ostial/proximal 1st om branch of the cx, and the ostium was ballooned again.A 2.25x15 sprinter legend balloon was used to perform 4 dilations.Another resolute onyx (2.75x22 mm) stent was then deployed, crushing the dislodged stent to the side so it was not involving the true lumen.Relevant history added to b7 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.

Manufacturer Narrative

Additional information: it was later stated that the stents were used to cover a dissection caused by ballooning the ostium of the diagonal, which was exhibiting around 50% stenosis.Agressive but not excessive force was used with both devices during delivery.It was stated that both stents flared when trying to pass a stent in order to advance into the diagonal branch it was later stated that it is thought that a medtronic device was used to dilate the ostium of the diagonal where the dissection occurred.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.

Manufacturer Narrative

Additional information: it was later reported that it was thought that the dissection occurred due to ballooning the ostium of the diagonal using a medtronic device.It was later stated that the 3.0x18mm stent caused the pinching of the om branch and that the ostium of the om branch had an 80% narrowing before the stents were deployed in the lcx.It was stated that it is not uncommon to get a little plaque shift to a side branch that already has a lesion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.

Manufacturer Narrative

Image analysis review: initial images show coronary angiographic (cag) views of the rca.No treatment was carried out.The patient had undergone previous coronary artery by-pass graft surgery (cabg) to the left anterior descending (lad).Angiographic images confirmed lesions in the proximal to mid lcx and the ostium of the om.The lcx and om were moderately tortuous and moderately calcified.Wire delivery to the distal vessel was completed with difficulty.Followed by what appears to be direct stenting with the 2.75x38mm resolute onyx stent in the proximal to mid lcx.This was followed by delivery and deployment of the 3.0x18mm resolute onyx in ostial to proximal lcx.Pinching of the ostium of the om was evident post deployment of the 18mm stent.The wire was re-positioned into the om and the ostium was ballooned with what appears to be the 1.5x15mm sprinter legend balloon, followed by ballooning with the 2.0x20 sprinter legend balloon.After the pre-dilatations with the 2.0 x 20mm sprinter legend balloon it appears that due to the tightness in the lesion the op ening of the lesion most likely resulted in a small dissection.Attempted delivery of a stent was not captured but the dislodged stent that is reported to be a 2.25 x 15mm resolute onyx stent is evident from the lm into the proximal lcx.The 2.75x22 mm resolute onyx stent was deployed from the proximal lcx back into the lm in order to crush the dislodged stent in the vessel.A stent was delivered and deployed in the om.Multiple post dilations were performed.The lcx and the om were treated successfully.There were no images showing the reported stent deformation.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.

Manufacturer Narrative

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: 10458470
• MDR Text Key: 204513746
• Report Number: 9612164-2020-03171
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556713
• UDI-Public: 00643169556713
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: RONYX22515UX
• Device Catalogue Number: RONYX22515UX
• Device Lot Number: 0009833921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 88