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

Catalog Number RSINT22518X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Deformation (2976)

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

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An attempt was made to use one resolute integrity rx drug eluting stent to treat a severely calcified, moderately tortuous lesion in the distal left anterior descending (lad) artery.The device was inspected with no issues noted.The lesion was pre-dilated.The device passed through a previously deployed stent, no resistance was noted when advancing the device and no excessive force was used during delivery.It was reported that a stent was implanted in the proximal left anterior descending (lad) artery.Later a distal lesion was identified in the same artery.The lesion was predilated.The resolute integrity device was passed through the previously deployed stent with no issues noted.The resolute integrity device was positioned in the distal lesion.On the first inflation, nominal pressure was applied.Contrast was observed however the balloon did not respond to the inflation. the stent was removed from the patient and it was observed that the balloon was damaged.A balloon burst, leak or catheter leak was reported.Stent failure was al so reported.

Manufacturer Narrative

Product analysis summary: the sheath and stylette returned loaded in the device.There was no resistance removing the sheath and stylette.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting a pin hole tear on the proximal marker band.The balloon failed to pressurise.The balloon material was jagged and uneven at the tear site.The device returned with balloon folds intact.No damage evident to the stent or distal tip.Blood was visible in the balloon.No other damage evident to the remainder of the device.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: patient history updated.The proximal lesion was pre-dilated with a 2.0 balloon, and subsequently a 2.5x30mm stent is implanted and is finally expanded with a 2.75 balloon in the proximal segment.After completion of the treatment in the proximal segment, it was noted that the lesion had subtotal obstruction in the middle third, a markedly extensive and eccentric plaque involving the origin of a second diagonal branch with antegrade flow timi ii and blush 0.The lesion was protected with a guide and pre-dilated with 2.0 balloon.The 2.25x18mm resolute integrity device navigated without any difficulty through the previously implanted stent in the proximal lesion and along the rest of the trajectory of the left anterior descending artery (lad).The device was removed from the patient without any complications.Once outside the patient it was observed that the balloon was damaged.A puncture at the level of the proximal point of the balloon was observed.The device was replaced by another stent which was implanted successfully.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: the lesion had 90-95% stenosis in the distal third of the anterior descending artery (ada).No prior stent preparation was performed.A 2.5x30mm resolute integrity stent was implanted in the proximal segment of the lesion first.The balloon never inflated as the contrast leaked from the device at the proximal part.A balloon burst did not occur as the device was never inflated.Patient weight provided.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: 14711757
• MDR Text Key: 294293243
• Report Number: 9612164-2022-02272
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSINT22518X
• Device Lot Number: 0010818068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 74 KG