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

Model Number RONYX35038UX

Device Problems Burst Container or Vessel (1074); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 08/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

One resolute onyx drug eluting stent was attempted to be used to treat a moderately calcified lesion in a moderately tortuous vessel. There was no damage noted to the device packaging. The device was inspected with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used. It was reported that a balloon rupture occurred during stent deployment, but it was unknown where the burst/leak occurred. The balloon rupture resulted in partial deployment of the stent. It was stated that the removal of the ruptured balloon resulted in stent dislodgement of the partially deployed stent and a coronary artery dissection. It was indicated that stent dislodgement occurred after removal of the device from the patient. No further patient injury reported. The procedure was completed using another resolute onyx device.

Manufacturer Narrative

Additional information: the correct event date is (b)(6) 2020. The balloon rupture occurred at 8atm. It was stated that the patient was initially relatively stable, and it was decided to transfer the patient to a tertiary center on iabp support for treatment as a precautionary step. While awaiting transfer, the patient's condition evolved so that it became safer to treat the patient at fhh (facility). The dissection was successfully treated with overlapping drug-eluting stents. The patient was then transferred to the tertiary facility for supportive care. An initial attempt was made to remove the partially inflated/deployed stent through the introducer sheath in the right femoral artery, but the stent could not be removed. Consideration then was made to snare the stent via the left femoral artery, but that site was needed for placement of an iabp to stabilize the patient. Plans were therefore made for a surgical cutdown to remove the stent. It was later stated that the stent remained in a right lower extremity artery and was successfully retrieved by surgical cutdown at the tertiary center after the patient stabilized from his stemi. The patient recovered and was discharged in good condition. 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: procedural images were provided for review. A calcified and moderately tortuous lesion can be seen in the proximal to mid left anterior descending (lad) artery. Images confirm the pre-dilatation of the lesion, but the images do not show the delivery of the stent, the attempted inflation or the reported balloon burst with partial stent deployment. Subsequent images show the removal of the delivery system and the dislodged stent towards the access point in the femoral artery. Final images appear to show greater patency of the lesion in the lad post treatment. Not other treatment images were provided. The root cause of the issues cannot be determined from the images provided. The stent dislodgement is 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: 10435719
• Report Number: 9612164-2020-03069
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• 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
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/17/2021
• Device Model Number: RONYX35038UX
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0009926856
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention