MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number UNK-CV-GWY-INT-DES

Device Problem Material Distortion (2977)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The physician deployed a resolute integrity of unknown size.The target lesion is unknown.The physician reported to have observed an obstruction on the angio after deployment of the stent.It was reported that plaque was protruding between stent struts.A second stent of unknown size or brand was deployed within the first stent.There were no patient complications reported.

Manufacturer Narrative

Evaluation, results: inherent risk of procedure (stent deformation); patients condition affected the effectiveness of the device (the target lesion appeared to be resistant to concentric deployment of the stent thus giving a possible irregular stent profile).No results available since.No evaluation was performed (device or procedural images were not returned for review).Conclusions: inherent risk of procedure (stent deformation).Device failure related to patient condition (the target lesion appeared to be resistant to concentric deployment of the stent thus giving a possible irregular stent profile).Unable to confirm complaint (device or procedural images were not returned for review).(b)(4).

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 3786281
• MDR Text Key: 18541462
• Report Number: 9612164-2014-00492
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-INT-DES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 05/02/2014
• 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
• Patient Outcome(s): Required Intervention