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

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

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.

Manufacturer Narrative

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

• Brand Name: SPRINTER RX
• Type of Device: CATHETERS, 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 Key: 6137626
• MDR Text Key: 61188714
• Report Number: 9612164-2016-01209
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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 Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR