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

Catalog Number ERES30030X

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

Still image review: the returned images appear to show stent deformation of the middle section of the complaint device.(b)(4).

Event Description

The procedure was prompted by acute coronary syndrome.It was reported that the physician was attempting to use an endeavor resolute rx drug eluting stent to treat a lesion in the middle of the rca with 99% stenosis, slight calcification and tortuosity.No issues noted during inspection prior to use.Lesion was pre-dilated.Resistance was noted while advancing to the lesion, no excessive force was used.It was reported that during the procedure, the stent deformed during positioning.The physician replaced it with another stent to complete the operation.No patient injury was reported as a result of the event please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (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

The stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the 16th and 17th distal stent wraps with struts raised.The distal shaft was kinked 7.9cm and 8.8cm distal to the guidewire entry port.There was slight deformation to the distal tip.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.

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: 6188428
• MDR Text Key: 62790825
• Report Number: 9612164-2016-01333
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Catalogue Number: ERES30030X
• Device Lot Number: 0008005126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2016
• 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: 70 YR
• Patient Weight: 70