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

Catalog Number ERES25024X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the dislodged stent returned stretched, bunched and deformed.Crimp impressions were visible on the exposed balloon surface.There was deformation to the distal tip.(b)(4).

Event Description

The physician used an endeavor resolute drug-eluting stent to treat a severely calcified and tortuous diffuse mid lad lesion exhibiting 80% stenosis and 50% stenosis in the proximal left main.The device was inspected prior to use with no issues noted.A guidewire was delivered to the distal lad.The physician pre-dilated the lesion using a non-mdt balloon.70% stenosis remained after pre-dilatation.It was reported that difficulties were encountered while attempting to deliver the endeavor resolute stent.The stent could not reach the target lesion.The stent reportedly dislodged during withdrawal.The physician used a balloon to inflate and successfully withdraw the dislodged stent into the guide catheter.It was reported that due to vascular factors, the stent dislodged again into the brachial artery.The physician used a snare to retrieve the stent.The physician continued the procedure using a guide catheter implanting 2 x endeavor resolute stents and 1 x non-mdt stent to complete the procedure with no stenosis remaining.The physician commented that the severe calcification and possible stent deformation was a contributing factor.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: 6188805
• MDR Text Key: 62857200
• Report Number: 9612164-2016-01338
• 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: 12/06/2016

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 Expiration Date: 04/08/2018
• Device Catalogue Number: ERES25024X
• Device Lot Number: 0008007187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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: 71 YR