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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number UNK-CV-GWY-NCEUPX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure, two resolute onyx rx coronary drug eluting stents were used to treat a moderately tortuous, moderately calcified lesion located in the left anterior descending (lad) artery and diagonal branch. It was later stated that the stents were used to cover a dissection caused by ballooning the ostium of the diagonal, which was exhibiting around 50% stenosis. The devices were inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. The devices did pass through a previously deployed stent. Resistance was encountered when advancing the devices. Aggressive but not excessive force was used with both devices during delivery. It was reported that the resolute onyx stent (pli 10, lot 0009833921) dislodged during delivery in the lad while attempting to deliver the stent to the diagonal branch. It was stated that both stents flared when trying to pass a stent in order to advance into the diagonal branch and was jailed by another stent that was deployed across the diagonal branch. Another stent was used to crush the dislodged stent into the wall of the mid lad. It was also reported that the second resolute onyx stent (pli 20, lot 0009983738) deformed in vivo during positioning. It was stated that the physician completed the procedure using another stent. It was later reported that it is thought that the dissection occurred due to ballooning the ostium of the diagonal using a medtronic device. The patient was reported to be alive with no further injury.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, 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 Key10586270
MDR Text Key208526959
Report Number9612164-2020-03636
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-NCEUPX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/25/2020 Patient Sequence Number: 1
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