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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

Journal name: vascular disease management title of article: inadvertent percutaneous coronary endarterectomy: an unreported complication of percutaneous coronary intervention issue: 2017;14 (1): e11-e15 note: date of event has been populated with date literature article was received prior to acceptance.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A pre-catheterization profile was performed and a radial approach with a 5 fr tiger non-medtronic catheter.The left coronary system showed no significant lesions, but mehran type iii in-stent restenosis (isr) was noted in the ostio proximal rca stent.Pci was performed using a mdt guide catheter (6f judkins 3.5) and a sprinter legend balloon (2 x 10mm).Post dilatation showed a longitudinal homogenous opacity moving from the proximal rca and embedded into the distal rca, causing timi 0 flow.An attempt to disintegrate the thrombus via balloon manipulation failed.Thrombosuction was successfully performed and flow restored across the rca.The ostio proximal rca was stented using a non-mdt stent.It was reported that most likely aggressive manipulation of the 6f fr judkins right catheter must have triggered the ostial rca dissection, leading to its total occlusion.Patient was discharged after 48 hours.

Manufacturer Narrative

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

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, 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 Key: 6663158
• MDR Text Key: 78275126
• Report Number: 9612164-2017-00807
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• 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: 05/26/2017
• 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: 66 YR