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

Catalog Number ERES22530X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product analysis: the stent was not present on the balloon.The stent was returned separately.The stent was stretched, bunched and deformed.Crimp im pressions were visible on the exposed balloon surface.The balloon folds remained intact.There was no indication that the device had previously been inflated.There was 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.

Event Description

A 3.5x24 mm endeavor resolute rx drug eluting stent was implanted successfully in a mildly calcified lcx.Device was inspected before use with no issues noted.Lesion was pre-dilated.No resistance was noted advancing to the lesion.It was then attempted to implant a second device, a 2.25x30 mm endeavor resolute, however it failed to cross the lesion and came into contact with the implanted 3.5x24 mm endeavor resolute stent causing the 3.5x24 mm stent to be pulled into the brachial artery.The 2.25x30 stent had started to move on the balloon off the stent delivery system and dislodged.A new balloon was used to retrieve the dislodged stent, pulling it into the guide catheter.It was retrieved successfully.The 3.5x24 mm stent broke in half on removal, with half remaining in the patients arm.No action was taken to remove the this portion from the patients arm.The other half was pulled out and removed from the patient.Patient status is reported as good.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

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: 6192933
• MDR Text Key: 63074147
• Report Number: 9612164-2016-01347
• 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
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2018
• Device Catalogue Number: ERES22530X
• Device Lot Number: 0007952133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR