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

Model Number RSINT22518X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  Injury  

Manufacturer Narrative

Product event summary # no dhr required.(b)(4) 17may 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion located in the proximal circumflex (cx) artery.The device was inspected with no issues noted.The lesion was pre-dilated.It was reported that the stent failed to cross the lesion.It was reported that the stent fell off the platform in vivo and was then removed using a coronary snare.Another stent was used to complete the procedure.It was stated that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information the dislodgment occurred while the device was advancing.Device evaluation summary: device returned for evaluation.Kinking was evident to the hypotube of the returned delivery system.The stent was not present on the balloon and did not return for analysis.The balloon folds were expanded and contrast was visible within the balloon.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.No other issues were noted.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 INTEGRITY RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12040016
• MDR Text Key: 257428432
• Report Number: 9612164-2021-02425
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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: 06/23/2023
• Device Model Number: RSINT22518X
• Device Catalogue Number: RSINT22518X
• Device Lot Number: 0010286988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR