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

Catalog Number RSINT27530UX

Device Problems Inaccurate Delivery (2339); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Physician attempted to treat lesion in the pda using a resolute integrity stent.The svg exhibited 99% stenosis (svg to pad-99% ostial calcified lesion), with unknown tortuosity/ calcification.No issues were noted with the device prior to use.It was reported that the stent became flared while passing through the svg to pda.An attempt was made to remove the sds and the guide catheter as a single unit from the patient when the flaring was noted however stent could not be retracted back into the sheath.It cannot be confirmed if positive pressure was applied to the stent during advancement towards the target lesion.It was reported that stent was deployed in the left radial artery.No patient complications were reported.Lesion was treated with a competitor stent.

Manufacturer Narrative

Evaluation method: (inherent risk of procedure, stent deformation).(patients condition affected the effectiveness of the device, 99% calcified lesion).(deformation problem).No results available since no evaluation was performed).(none, no device received for evaluation).Evaluation conclusion: (device failure/lack of effectiveness related to patients condition, 99% calcified lesion).(known inherent risk of procedure, stent deformation).(material deformation); (inaccurate delivery); (no consequence or impact to the patient).(b)(4).

Event Description

Cine image review: review of procedural images confirm that the stent became flared while passing through the svg to the pda.The patients lesion morphology appears poor in the vessel.It appears that the stent was slightly inflated prior to being in the correct position.The stent then appeared to be implanted in the left radial artery and the stent did not expand uniformly possibly due to the presence of calcification in the vessel.

• Brand Name: RESOLUTE INTEGRITY 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: 3931270
• MDR Text Key: 4573124
• Report Number: 9612164-2014-00913
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2015
• Device Catalogue Number: RSINT27530UX
• Device Lot Number: 0007012108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2014
• Date Device Manufactured: 01/24/2014
• 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: 00076 YR
• Patient Weight: 48