MAUDE Adverse Event Report: MPRI ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 479888

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/17/2023

Event Type  malfunction  

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.

Event Description

It was reported that an attempt was made to use one guidewire in a non-tortuous, non-calcified lesion in the coronary sinus vein.The device was inspected with no issues noted.The wire tip was not formed by the physician.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the guidewire.Excessive force was not used during insertion/delivery.It was reported that guidewire detachment in vivo occurred and resistance was experienced during insertion.After successful coronary sinus cannulation with a guide catheter, the guidewire was introduced through the left ventricle (lv) lead with no resistance or complications.However, after cannulating the posterolateral vein and advancing the lv lead over the guidewire, resistance was experienced when attempting to retract the lead.The lead and guidewire did not retracted entirely and part of the guidewire remained in the patient.It was detailed that the broken guidewire portion was aspirated via the guide catheter.The detached portion was removed from the patient.The guidewire and lead were replaced with a competitor guidewire and new lead.No patient complications have been reported as a result of this event.

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.

Event Description

It was reported that an attempt was made to use one guidewire in a non-tortuous, non-calcified lesion in the coronary sinus vein.The device was inspected with no issues noted.The wire tip was not formed by the physician.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the guidewire.Excessive force was not used during insertion/delivery.The subclavian procedural approach was used.The guidewire had not been successfully with other devices prior to the difficulties occurring.It was reported that guidewire detachment in vivo occurred and resistance was experienced during insertion.After successful coronary sinus cannulation with a guide catheter, the guidewire was introduced through the left ventricle (lv) lead with no resistance or complications.However, after cannulating the posterolateral vein and advancing the lv lead over the guidewire, resistance was experienced when attempting to retract the lead.Resistance was not noted when loading the guidewire into the lead and was felt only when retracting.The lead and guidewire did not retracted entirely and part of the guidewire remained in the patient.It was detailed that the broken guidewire portion was aspirated via the guide catheter.The detached portion was removed from the patient.The guidewire and lead were replaced with a competitor guidewire and new lead.The patient is alive with no injury.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STABILITY QUAD MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16816668
• MDR Text Key: 314024637
• Report Number: 2649622-2023-10420
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P080006
• 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: 05/18/2023

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 Expiration Date: 05/20/2024
• Device Model Number: 479888
• Device Catalogue Number: 479888
• Device Lot Number: QFX093663V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/18/2023
• Date Device Manufactured: 06/07/2022
• 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