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

Model Number	SPL12512X
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the removal of one sprinter legend device following inflation at nominal pressure in a moderately tortuous, severely calcified lesion with 60% stenosis in the distal diagonal branch of the artery, a detachment at the tip of the balloon catheter occurred.Due to the extreme calcium, the balloon catheter was delivered with slight difficulty.The balloon was inflated once to nominal pressure and upon removal sheered off.Attempts were made to snare, rewire, and use a suction device to remove the detached portion, but the distal portion of the catheter remained in the patient's distal diagonal artery.The device was inspected with no issues noted.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance or excessive force was not encountered during delivery.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: the detached portion of the device was not secured within the vessel, but was floating distal.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: the balloon was being used to pre-dilate the lesion.Approximately 10mm of the distal tip of the balloon catheter, including the marker band was left in the body.There is no future plan to remove the detached portion embedded in the vessel.The patient is alive and doing well with no further injury.Image analysis: one still image was returned for analysis.Part of a device is shown in the image with a shelf carton in the background however the image is of poor quality, and it cannot be determined what section of the device is shown or if there is a detachment evident.The image is of too poor a quality to confirm any complaint.A lot number seen on the shelf carton matches the lot number reported.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SPRINTER LEGEND RX
• Common Device Name: 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: 21109774
• Report Number: 9612164-2025-00144
• Device Sequence Number: 8733126
• Product Code: LOX
• UDI-Device Identifier: 00643169271760
• UDI-Public: 00643169271760
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: SPL12512X
• Device Catalogue Number: SPL12512X
• Device Lot Number: 227941711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/09/2025; 02/04/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/04/2025; 02/10/2025
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female