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

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Occlusion (1984); Stenosis (2263); Vascular Dissection (3160)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

Journal of the american college of cardiology vol 71, no 16, suppl s, 2018 crossing left anterior descending artery chronic total occlusion using parallel wire technique and intravascular ultrasound guidance.If information is provided in the future, a supplemental report will be issued.

Event Description

Angiogram showed 90% stenosis in rca, chronic total occlusion of the lad with collateral from lad to 1st diagonal and chronic total occlusion of the cx with collateral from circumflex to obtuse marginal.A resolute integrity des 3.50 x 24mm was implanted in the rca successfully.A staged procedure was planned to treat cto of lad at a later date.Pci was performed for the lad cto lesion.A sprinter 1.25x6mm otw balloon was attempted but could not cross.Other non-medtronic devices were attempted and failed to cross the lumen.A non-medtronic microcatheter support was used to cross the lesion.Flow of lad was restored but extensive dissection was found.Three non-medtronic stents were implanted in the lad.Final result showed lad timi flow of 3.

Manufacturer Narrative

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

• Brand Name: SPRINTER OTW
• 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: 7682187
• MDR Text Key: 113793689
• Report Number: 9612164-2018-01709
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• 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: 08/08/2018
• 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: 52 YR