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

Catalog Number ERES30038X

Device Problem Material Distortion (2977)

Event Date 11/04/2014

Event Type  Injury  

Event Description

A 3.0 x 38 endeavor resolute stent was implanted in the lad to treat a moderately calcified <(>&<)> stenosed lesion.The lesion was pre-dilated.The stent was deployed at 18 atm for 30 seconds in the osteo proximal segment.After deployment, it was noted that the stent had fractured.The physician covered the fractured stent with a 3.5 x 18 mm endeavor resolute.The lesion was post dilated.No patient complications were reported.Image review: the procedural images confirm a tortuous and calcified proximal lad lesion.The lesion is pre-dilated.The eres30038x stent is deployed at 18atms.The stent is post-dilated and kbt is performed in the proximal stent area.Subsequent images show what appears to be a separation of stent crowns in the mid stent segments at the location of a bend in the vessel.Another smaller stent is deployed in this area.The images do confirm stent deformation/material distortion.Please note that this device (endeavor resolute) is distributed outside the united states; however, it is similar to the united states distributed product resolute integrity.

Manufacturer Narrative

Evaluation, results: patient's condition affected effectiveness of device (lesion morphology); inherent risk of procedure (stent deformation); no results available since no evaluation performed (device not returned for evaluation); failure to follow instructions (balloon inflated beyond rate of burst pressure); deformation problem (stent).Evaluation, conclusions: failure to follow instructions (balloon inflated beyond rate of burst pressure).Device failure/lack of effectiveness related to patient condition (lesion morphology); inherent risk of procedure (stent deformation).(b)(4).

• Brand Name: ENDEAVOR RESOLUTE 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: 4300451
• MDR Text Key: 15326463
• Report Number: 9612164-2014-01606
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2016
• Device Catalogue Number: ERES30038X
• Device Lot Number: 0007196105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Date Device Manufactured: 06/19/2014
• 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
• Patient Age: 00059 YR