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

Model Number SPL12510X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use a sprinter legend rx balloon to treat a calcified and moderately tortuous lesion in the proximal left circumflex with 90 % lesion stenosis.No damage noted to the device packaging.No issues were noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed.The lesion was pre-dilated.A rotoblator was used in the distal left main into lad to treat the calcified lesion followed by a 2.0 mm and a 3.0 mm non-medtronic balloons.The non-medtronic balloons were used prior to using the sprinter legend 1.25 mm, but both non-medtronic balloons did not cross.The device did not pass through a previously deployed stent.It was reported that a balloon burst/leak occurred.The balloon burst in the proximal left circumflex at 18 atm.It was reported that the marker band dislodged after deployment in the proximal left circumflex.It was observed that the marker band migrated from the proximal left circumflex to a branch of the left circumflex.An attempt was made to recover the dislodged marker band.A non-medtronic catheter was advanced over the tip of the balloon cathete r, in the left cx, then the non-medtronic catheter, guidewire and guide catheter were withdrawn out of the body to try to retrieve the sprinter legend marker band from the mid-left circumflex artery, but was not successful.The procedure was completed by placing a stent in the proximal left circumflex.The patient is stable and was discharged from hospital.

Manufacturer Narrative

Additional information: patient had a medical history of coronary heart disease and underwent multiple cardiac procedures.The lesion was reported to be extremely calcified.Evaluation summary: the balloon returned with blood visible in the balloon and inflation lumen.There appeared to be a detachment at the most distal end of the distal shaft, 31cm distal to the guidewire entry port.Stretching was apparent proximal to the detachment site.The most distal detachment material was jagged and uneven.Kinking and stretching was visible along the complete distal shaft.The balloon failed negative prep.On pressurisation of the device, a leak was observed along the distal shaft.The device failed to maintain pressure.Upon visual inspection of the device, it was evident that the outer material of the distal shaft appeared cut, 23.5cm distal from the gw entry port.No marker bands were returned with device.Image review: two images were returned.The first image captured the packaging of the non-medtronic guidewire used in the procedure.The second image captures the lesion morphology of the circumflex lesion as reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: the balloon portion of the device was not returned.Image review: review of the procedural images provided confirm the presence of a severely calcified stenotic lesion in the proximal part of the lcx artery.It was reported that during the treatment of the lesion in the proximal lcx with semi compliant balloon, the burst occurred.The inflation pressure was 18 atm.It was reported that the radiopaque marker from the balloon remained in the proximal lcx.After attempted retreat, the marker band migrated from proximal lcx to distal branch of the lcx and that can be confirmed from the procedural images.The procedure was completed by placing a stent in the proximal lcx.Although, no images of the balloon burst were provided.Severely calcified nature of the proximal part of the lcx and the proximal part of the lad can be confirmed from the images.The possibility exists, as it was reported, that the physician used a pressure of 18 atm and that the balloon burst occurred as a consequence of the extreme inflation of the balloon but that cannot be confirmed from the images.It is reported that the balloon was inflated to 18 atm, 6 atms above rated burst pressure (rbp), which is 12 atm for the 1.25 sprinter legend balloon but that cannot be confirmed from the procedural images as no images were provided showing the delivery and expansion of the sprinter legend device.In order for the marker to migrate off the inner shaft of the delivery system the balloon and distal tip material would have detached, and the inner shaft necked.There is no information in the file to confirm.But migration of the inner shaft marker to a distal vessel is confirmed.Although the calcified nature of the vessel may have contributed to the burst.The user also failed to follow instructions and inflated the balloon in excess of rbp.This is more like to have resulted in the balloon burst and the subsequent marker band migration issue.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: 7337095
• MDR Text Key: 102304752
• Report Number: 9612164-2018-00505
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169271753
• UDI-Public: 00643169271753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: SPL12510X
• Device Catalogue Number: SPL12510X
• Device Lot Number: 214371590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• 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 Age: 75 YR
• Patient Weight: 127