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

Model Number SPL25015X

Device Problems Burst Container or Vessel (1074); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: there is no damage to the distal tip of the device.In attempt to inflate the balloon, the balloon failed negative pressure and could not be inflated.There was a longitudinal clean tear along the length of the balloon.However, at the distal end of the balloon, the balloon material was jagged and uneven along the tear.(b)(4).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 the physician was attempting to use a sprinter legend rx balloon to treat an unknown lesion.No anatomical abno rmalities were reported.It is reported that the balloon burst during balloon inflation.No patient injury reported.

Manufacturer Narrative

Additional information received: it was reported that the lesion being treated exhibited 90% stenosis, no calcification or vessel tortuosity.The device was inspected prior to use with no issues noted.Negative prep was performed with no issues noted.During the procedure, no resistance was encountered while advancing the device and no excessive force was used.It is reported that the balloon suddenly burst during initial balloon inflation at 12 to 14atm.It was reported that there was a sudden drop in pressure and the device completely failed to inflate.The physician used a nc balloon to complete the procedure.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

Cine image review: images confirm the treatment was completed in a diffusely diseased lad.The target lesion reported to have exhibited 90% stenosis appears to have been located in the mid lad in a moderately tortuous part of the vessel.The images failed to identify the presence of calcification.The images failed to confirm the reported balloon burst.The initial balloon inflated at the target lesion site appears to have fully expanded and there was no evidence of contrast leak or a burst.Subsequent angiographic images of the vessel post balloon appeared to show incomplete resolution of the stenosis.A shorter balloon was delivered and inflated at the lesion resulting in greater resolution of the stenosis.Although other balloon inflations were carried out there is no evidence of a balloon burst.Two stent were ultimately deployed in the distal and proximal lad.

Manufacturer Narrative

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

Manufacturer Narrative

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, PERCUTANEOUS
• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5764466
• MDR Text Key: 48619038
• Report Number: 9612164-2016-00636
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2019
• Device Model Number: SPL25015X
• Device Catalogue Number: SPL25015X
• Device Lot Number: 211103224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2016
• 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: 63 YR