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

Catalog Number ERES22530X

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

The stent was positioned on the balloon between the marker bands as per specifications.There was visible damage to the 7th, 8th, 9th and 10th distal wraps with numerous struts raised.Resistance was noted when loading the sheath due to the 9th distal wrap deformation.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

It was reported that the physician was attempting to use an endeavor resolute (rx) drug eluting stent to treat a severely calcified and moderately tortuous rca lesion exhibiting 85% stenosis.It was reported that the device was removed from its packaging as per ifu and inspected with no issues noted.The lesion was pre-dilated with a solarice balloon.Resistance was encountered when attempting to cross the target lesion and excessive force was used.The endeavor resolute failed to cross the target lesion.It was reported that struts of the stent appeared damaged, therefore the stent was replaced with another endeavor resolute of the same size.The procedure was completed without complication.No patient injury.The physician commented that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed device (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

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

• 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: 5808433
• MDR Text Key: 50125626
• Report Number: 9612164-2016-00695
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110013
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2016
• Device Catalogue Number: ERES22530X
• Device Lot Number: 0007199973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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 Age: 54 YR
• Patient Weight: 84