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

Catalog Number	SPL12515WL
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sprinter legend otw balloon dilatation catheter was used in a midly tortuous, severely calcified lesion in the mid lad.Lesion had 90% stenosis.The lesion was pre-dilated.There was no damage noted to the sprinter legend otw packaging.There were no issues noted removing the device from the hoop/ tray.The balloon catheter was inspected and negative prep performed with no issues noted.The balloon catheter did not pass through a previously deployed stent.Resistance was encountered when advancing the balloon however excessive force was not applied.During first balloon inflation at 10 atms the balloon burst.Removal difficulties were encountered and the balloon and marker detached from the catheter shaft and were left in the lad.The detached balloon marker was not removed from the patient.Patient underwent cabg the next day in a different hospital but passed away after the procedure.Mesenteric ischemia is reported to be the cause of death.It is reported that the sprinter legend device was indirectly the cause of death due to bypass surgery with balloon material in the coronary artery.
Additional Manufacturer Narrative
Additional information: the lesion was pre-dilated with a 1.5 x 8cm sprinter balloon.The 1.5 x 8cm balloon was not completely across the lesion, but the distal balloon portion was across the proximal lesion or at least into the lesion.The 1.5 x 8cm sprinter balloon did rupture also indicating it was within the calcified portion of the lesion.The next balloon was the 1.25 x 15mm sprinter legend balloon.The sprinter legend balloon was completely across the mid lad lesion.There was nothing on cine of the catheter pullback post rupture, but there was a picture of the balloon marker in the prox lad and total occlusion of the lad distal to the balloon marker stripped from the catheter.Ref: medwatch mw5079410 - the patient was placed on iabp prior to the transfer to the second hospital.Device evaluation: the material at detachment site appeared to be torn and uneven.Bunching of the material on the distal outer was evident.There was a detachment evident at the distal inner.There was no balloon material or marker bands visible on the delivery system.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The first balloon used to pre-dilate the lesion was a 1.5 x 8mm sprinter legend balloon.The 1.5mm sprinter legend was inspected before use with no issues noted.Negative prep/purging was performed on the device prior to use with no issues noted.Resistance was noted while advancing the device to the lesion.Excessive force was not used.The burst of the 1.5mm sprinter legend occurred on first inflation at 12atm.The device was not moved or repositioned in the lesion prior to the burst.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND OTW
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7804264
• Report Number: 9612164-2018-02115
• Device Sequence Number: 1290735
• Product Code: LOX
• UDI-Device Identifier: 00643169854963
• UDI-Public: 00643169854963
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2018

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 Expiration Date: 02/20/2021
• Device Catalogue Number: SPL12515WL
• Device Lot Number: 214951797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 09/18/2018; 10/26/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/14/2018; 10/16/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 79 YR