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

Catalog Number RSINT30012UX

Device Problems Device Slipped (1584); Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/29/2015

Event Type  Injury  

Event Description

It was reported that the physician was attempting to use a resolute integrity (rx) drug eluting stent to treat a lesion in the svg exhibiting heavy calcification and 95% stenosis.The device was removed from its packaging and was prepped and inspected as per ifu with no issues noted.The lesion was pre-dilated twice.It was reported that the stent did not pass the lesion primarily, so the physician used a guideliner.It was reported that resistance was encountered while advancing the device and force was required.It was reported that there was difficulty withdrawing the stent back through the lesion.The stent then slipped when trying to recapture and dislodged in svg to rca.The stent delivery system was removed from patient and the stent remained in patient on the guidewire.A 1.25 balloon was advanced on wire and through the stent lumen.Balloon was inflated and the stent deployed.Stent deployment position covered proximal area of initial lesion.Another stent was utilized which covered the remaining distal portion of lesion and successfully deployed.Procedure reported as completed and patient was stable.

Manufacturer Narrative

Results: stent embolization.Lesion with heavy calcification and 95% stenosis.Force used to when resistance was encountered.No device received for evaluation as device was implanted.No device received for evaluation as device was implanted, no procedural images received.Conclusions: lesion with heavy calcification and 95% stenosis.Force used to when resistance was encountered.Stent embolization.No device received for evaluation as device was implanted, no procedural images received.(b)(4).

• 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: 4800776
• MDR Text Key: 5830348
• Report Number: 9612164-2015-00813
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2016
• Device Catalogue Number: RSINT30012UX
• Device Lot Number: 0007262452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Date Device Manufactured: 08/18/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 00085 YR
• Patient Weight: 70