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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 02/03/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The still images from the journal article capture the bifurcation lesion with severe stenosis, the stent delivery and deployment, together with the angulation of the sbw at the bifurcation site. Another image captures a smooth angiogram of the vessel after the removal of the entrapped guide wire, post dilation and stenting of the lad ostium. Journal name: tzu chi medical journal title: side-branch wire entrapment: early recognition ref: http://dx. Doi. Org/10. 1016/j. Tcmj. 2014. 12 event date: date available on line.
 
Event Description
Angiography revealed cad with 80% stenosis of the proximal lad artery at the bifurcation of the first diag branch. Due to a coronary bifurcation lesion, side branch wire (sbw) protection with provisional stenting was done. After wiring the lad and the d1 arteries the physician dilated the lesion using a 3. 0 x15-mm sprinter balloon to 8 atm. It was reported that a dissection occurred at the lesion site. The physician advanced an integrity bare metal stent across the lesion and resistance was encountered. Additional support using a guide catheter allowed the stent to cross and it was inflated to 8atm. It was noted that the stent was not fully expanded, proximal displacement occurred and an increased acute angulation of the sbw at the bifurcation site. It was reported that inspection was carried out using a fluoroscope and it was noted that the sbw was wrapped 270 degrees around the stent, rendering extraction of the sbw highly difficult and posing a high likelihood of wire entrapment. An attempt was made to pull the wire with force along with low-pressure of the stent balloon to protect the lad stent, but the sbw only moved fractionally. A non-mdt micro-catheter was inserted in with the entrapped wire to enlarge the space between the vessel and the stent. The physician was able to push the microcatheter approximately halfway into the stent and was able to successfully remove the wire out using more force. They proceeded to post-dilate the balloon to 16atm for stent expansion and implanted another 4. 0x15mm integrity stent near the first stent for dissection in the lad ostium. The post pci course was smooth; the patient was followed up in the cardiology clinic for 6 months without any related complaints.
 
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Brand NameSPRINTER RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6137626
MDR Text Key100959411
Report Number9612164-2016-01209
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received11/03/2016
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: 12/01/2016 Patient Sequence Number: 1
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