MAUDE Adverse Event Report: MEDTRONIC IRELAND DRIVER RX; STENT, CORONARY

Catalog Number UNK-CV-GWY-DRIVER

Device Problem Material Distortion (2977)

Patient Problem Myocardial Infarction (1969)

Event Date 01/30/2013

Event Type  Injury  

Event Description

The source literature reported that the patient had cardiac status of stable angina at time of index procedure.Angiography revealed a severe proximal rca stenosis.The patient had a 4.0 mm x 30mm driver bare metal stent implanted in the rca with an excellent angiographic result.Twelve months later the patient suffered an nstemi.Optical coherence tomography (oct) revealed that multiple prominent 'diverticuli' noted behind the stent struts were a result of late aquired bms malapposition (lasma) with poor neointimal coverage of the affected struts.It was also noted that microthrombi formation within the outpouchings behind the struts would be the likely cause of the nstemi.The patient was managed by reinstitution of dapt.The article concluded that positive remodelling appears to be the most likely cause of lasma in the patient, in light of the fact that initial stenting was performed for stable angina secondary to a lesion with simple angiographic morphology and a definite increase in vessel size demonstrated on the follow up oct at t he site of lasma.

Manufacturer Narrative

Evaluation, results: inherent risk of procedure (mi is listed in the driver instructions for use (ifu) as a potential adverse event of a pci procedure); patient condition affected effectiveness of the device (there was a definite increase in vessel size as demonstrated in the follow-up oct); no results available since no evaluation was performed.No device returned.Conclusion: known inherent risk of procedure (mi is listed in the driver instructions for use (ifu) as a potential adverse event of a pci procedure); device failure/lack of effectiveness related to patient condition device (there was a definite increase in vessel size as demonstrated in the follow-up oct).(b)(4).Reference: optical coherence tomography of late acquired bare metal stent malapposition: bare metal stent ¿diverticulosis¿.Luis et al, heart, lung and circulation 2013 - 22: 688-689.

• Brand Name: DRIVER RX
• Type of Device: STENT, CORONARY
• 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: 3801925
• MDR Text Key: 18571742
• Report Number: 9612164-2014-00504
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-DRIVER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• 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
• Treatment: ASPIRIN
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 00069 YR