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

Catalog Number ERES30038X

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Perforation (2001); Unspecified Tissue Injury (4559)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.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 endeavor resolute rx coronary drug eluting stent to treat a mildly tortuous, non-calcified lesion exhibiting 95% located in the distal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated using a sprinter 2.5 x 15mm ptca balloon catheter.It was reported that stent deformation occurred in vivo post deployment.It was stated that the device was inflated at 14atm for around 15 seconds and a strut fracture occurred that was visible on fluoroscopy along with a leakage of dye.It was stated that a type-3 perforation occurred that was covered using a stent.Patient was stable and discharged the next day.

Manufacturer Narrative

Additional information: no resistance was noted while advancing the device to the lesion.Excessive force was not used during delivery.The stent device did not pass through a previously deployed stent.A non-medtronic stent was used to cover the perforation.Correction: intervention ticked adverse event <(>&<)> product problem selected 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: four still fluoroscopy images and one mp4 video provided for procedural image review.Images of the lad prior to stent deployment were not provided and images showing treatment post perforation were not provided.The images show the lad post stent deployment in the proximal lad.The distal vessel to where the stent was deployed appears much narrower than the proximal vessel where the stent is deployed.The deployed stent profile confirms that the stent was not uniformly expanded throughout its entire length.Full concentric stent deployment appears to have been impacted by a severely diseased fibrotic and calcified vessel.The stent does not appear to have been deformed but has confirmed that the vessel morphology.The reported perforation is confirmed at the distal end of the deployed stent.This area of the stent does not appear the have fully expanded and given that a perforation appeared at this location and the vessel distal to this location is extremely narrow, this suggests that the vessel is severely diseased.The severe disease in the vessel appears to have prevented the full concentric expansion of the stent and the action of device expansion in the vessel resulted in the perforation of the vessel.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: ENDEAVOR RESOLUTE RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11272961
• MDR Text Key: 230061954
• Report Number: 9612164-2021-00486
• 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,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Catalogue Number: ERES30038X
• Device Lot Number: 0010369219
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68