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

Catalog Number ERES35030X

Device Problem Fracture (1260)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/04/2014

Event Type  Injury  

Event Description

Physician implanted 2 endeavor resolute drug eluting stents; a 2.75x30mm in the lad and a 3.50x30mm in the lm to lad.The lesion was post-dilated with balloons (3.5 15mm and 2.5 15mm).After dilation, a strut fracture was observed on the resolute 3.50*30mm.The physician implanted another brand stent 3.50 12mm to cover this stent.It was confirmed that no abnormality was noted during preparation or inspection of the relevant endeavor resolute device prior to use.No resistance noted between the relevant device and other devices used in the procedure and/or during delivery to lesion.The endeavor resolute was inflated to 12atm with no difficulty noted during stent deployment.The balloon of the device successfully deflated post stent deployment and no difficulty experienced during removal of the delivery system.No additional clinical sequelae were reported.Please note that this device (endeavor resolute rx) is distributed outside the united states; however, it is similar to the united states distributed product (resolute integrity rx).

Manufacturer Narrative

Evaluation, results: inherent risk of procedure (stent fracture); deformation problem; no results available since no evaluation performed (device or procedural images not provided for review); no device received for evaluation.Conclusions: known inherent risk of procedure (stent fracture); unable to confirm complaint (device or procedural images not provided for review).(b)(4).

Manufacturer Narrative

Deformation problem, heavy plaque load at the opening of anterior descending branch, calcified and constricted vessel.Conclusions: heavy plaque load at the opening of anterior descending branch, calcified and constricted vessel.(b)(4).

Event Description

There was 90% stenosis in anterior descending branch, without tortuosity or calcification.Before stent implantation, the lesion was pre-dilated at pressure of 8 atm.After pre-dilation, residual stenosis was 60-70%.There was 30% stenosis in left main coronary artery, without tortuosity or calcification.However, ivus confirmed heavy plaque load at the opening of anterior descending branch and plaque load of about 30-40% in distal segment of left main coronary artery, so a stent had to be implanted in left main coronary artery.Image review: review of the coronary angiograph and ivus images returned show the lad and lm vessels to be calcified and constricted.The images show the pre-dilation being performed, the stent was deployed in the lm to lad vessel; the stent indicated that it had an incomplete concentric stent expansion on the proximal end.The stent was post-dilated and there was an improvement in the stent profile.Images of the stent post dilation show no evidence of weld break or material break in the suspected area of the strut fracture.

• 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: 3847287
• MDR Text Key: 18868319
• Report Number: 9612164-2014-00553
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Catalogue Number: ERES35030X
• Device Lot Number: 0006577487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Date Device Manufactured: 11/28/2012
• 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: 00051 YR