MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number SPL25020X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Inflation Problem (1310); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2023

Event Type  Injury  

Event Description

An attempt was made to use one sprinter legend rx balloon catheter to treat a lesion in the proximal left anterior descending (lad) artery.The device was inspected with no issues noted. it was reported that balloon deflation difficulties occurred.It was detailed that when inflating the balloon, it felt a little different than usual.The balloon would not deflate at the lesion site so the guide and balloon were brought into the aorta, where the balloon was burst in order to get it out.Manual aspiration was used.The procedure was completed without significant incident.The patient is alive with no further injury.

Manufacturer Narrative

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: event date it was reported that it is unsure if the balloon was inflated above rated burst pressure to burst it, however it is presumed that this is what occurred.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 50-60% stenosis.Physiological assessment of the lad showed that there was flow limitation to the lad as well.Most of this was confined from the proximal lad to the distal left main (lm) so a decision was made to stent the proximal lad into the lm ostium.Intervention was first carried out to the left circumflex (cx) artery where the patient felt a significant amount of chest discomfort and shortness of breath (sob).The cx was predilated with a 3.00 balloon and a 3.5x16mm non-medtronic (mdt) stent was implanted and post dilated with a 4.00 balloon.Intravascular ultrasound (ivus) showed excellent stent opening on the ostium of the cx with complete resolution of the lesion.Negative prep/purging was performed on the device prior to use with no issues noted.The device was being used to pre-dilate the lesion.Resistance was not noted while advancing the device to the lesion.A 50/50 concentration of contrast/saline was used.The balloon deflation difficulties occurred after the first inflation, and the balloon did appeared to not hold at 14 atm pressure despite trying.A non-medtronic indeflator was used.The balloon failed to deflate.Manual aspiration was attempted with a 20cc syringe to manually deflate balloon, however, this failed and did not deflate the balloon.The device was not moved or repositioned while inflated, only moved after the deflation difficulties in order to bring to the aorta to burst the balloon.Wires were not used to puncture the balloon.Once the balloon was burst it was possible to be removed in the usual manner over the wire.Intervention was not needed to remove the device from the patient.To complete the procedure a 3,00mm balloon was used for pre-dilation, followed by deployment of a 3.5x33mm non-mdt stent at 16 atm.Proximal optimization was performed with a 5.00 balloon into the lm.Ivus showed timi iii flow from the lm into the lad and the cx.At the end of the procedure there was complete resolution of the chest pain and sob experienced during the cx intervention.Patient gender and weight.Product analysis: the device was returned for analysis.The device returned with balloon folds expanded.Proximal balloon bond and inflation lumen were bunched.The balloon failed negative prep.An attempt was made to inflate the balloon but due to bunched proximal bond and a longitudal tear found along the balloon¿s working length, the balloon could not be inflated.Stretching was evident to the transition shaft immediately proximal to a tear in the guidewire entry port.No other deformation 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

Image analysis: four fluoroscopic sequences were provided for review.The first image shows the presence of an uninflated delivery system in the proximal vessel.The second image shows that the balloon was successfully inflated.The reported device removal was not shown on the images.The third and fourth images show the left coronary system with contrast injection.The pre-dilation balloon has been removed from the vessel.The images failed to identify the root cause of the reported deflation difficulties.Correction: the lesion was moderately calcified.Annex a 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: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17734657
• MDR Text Key: 323249770
• Report Number: 9612164-2023-04140
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P790017
• 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,Followup,Followup
• Report Date: 01/23/2024

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 Model Number: SPL25020X
• Device Catalogue Number: SPL25020X
• Device Lot Number: 223574966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 09/19/2023; 10/10/2023; 01/19/2024
• Supplement Dates FDA Received: 10/06/2023; 10/31/2023; 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG