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

Model Number RSINT30012X

Device Problems Entrapment of Device (1212); Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device was returned for analysis.A kink was evident to the hypo-tube.The guidewire returned loaded in the device.The guidewire was removed with no issues noted.The stent had displaced proximally on the balloon and was not positioned on the balloon between the marker bands as per specifications.The proximal stent wraps were positioned over the proximal marker band.The stent was not positioned against the distal pillow as per specification.Crimp impressions were visible on the exposed balloon surface.No deformation evident to the stent.A twist was evident to the transition shaft.A tear was evident to the guidewire entry port.No deformation evident to the distal tip.Image analysis: two still images were received for analysis.Image one shows the back of a resolute integrity shelf carton, confirming the device size and lot number.Lot number 0011415079 and size 3.0mm x 12mm.Image two shows the top section of two resolute integrity shelf cartons stacked on each other.Two sterile sleeves are also visible under the boxes with a section of the hypo-tube visible.Device sizes are visible, one 2.75mm x 14mm and one 3.0mmx 12mm.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.

Event Description

An attempt was made to use two resolute integrity rx coronary drug eluting stents to treat a lesion in the proximal left anterior de descending (lad) artery.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.Resistance was encountered when advancing the devices.Excessive force was not used during delivery.It was reported that the first stent (rsi nt30012x) failed to cross the 0.014 non-medtronic guidewire.The tip of the stent was stuck inside the non-mdt guidewire.The second resolute integrity stent (rsint27514x) was used with a different 0.014 non-medtronic guidewire and the same issue occurred.Both stents did enter the patient's vasculature.After the guidewires were inserted into the patient the stents followed but the tip of the stents stuck to the guidewires.The guidewires were removed from the vasculature along with the attached stents.The guidewires were flushed and examined with no issue.The same size guidewires were used successfully with other devices without any issue.The patient is alive with no injury.

Manufacturer Narrative

Additional information: annex d code.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17866536
• MDR Text Key: 324931736
• Report Number: 9612164-2023-04465
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSINT30012X
• Device Catalogue Number: RSINT30012X
• Device Lot Number: 0011415079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 60 KG