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

Catalog Number RSINT35009X

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient had 3 resolute integrity rx drug eluting stents implanted in the lad in (b)(6) 2016.One of the stents was a 3.5 x 9mm resolute integrity rx drug eluting stent implanted in the bifurcation of the lad and the cx.Approximately 8 weeks later the physician was attempting to treat a lesion in the cx exhibiting 80% stenosis using a 3.0 x 22mm resolute integrity rx drug eluting stent.No damage was noted to the device packaging and no issues noted removing the device from the hoop/tray.The device was inspected with no issues noted.The lesion was pre-dilated.It was reported that during the procedure, the physician used two wires to place the resolute integrity stent in the cx.The first wire was a (bmw) middle weight wire.No resistance was encountered when advancing the 3.0 x 22 mm device and no excessive force used.The stent was deployed successfully and the delivery system was removed successfully.The first wire stuck in the vessel between the bifurcation and the target lesion.It is reported that the stent migrated when the first wire was removed.No patient injury reported.Three unknown brand stents were implanted in the left main, prox.Lad and prox.Cx as intervention.

Manufacturer Narrative

Evaluation summary: analysis of returned stent confirmed that the stent that migrated was the previously implanted 9mm resolute integrity rx stent.The stent and two guide wires returned for analysis without the delivery system.The stent was bunched, stretched and deformed.The returned stent was confirmed to a resolute integrity 9mm stent.Image review: review of the procedural images confirm the presence of previously deployed stents at the bifurcation between the lad and the lcx.For treatment of the lcx the procedural wires appear to be delivered through a distal the cell of the previously deployed stent.The lcx lesion was treated successfully with stent deployment.Image show that the stent structure appears to have been disrupted at the bifurcation between the lcx and the lad and the procedural wire appears to be caught inside the stent in the left main.This stent was subsequently pulled from it's original place of deployment by the procedural wire.This confirms the reported migration.The vessel was then rewired and after multiple balloon inflations and stent deployments the patency of the vessels were restored.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 5920233
• MDR Text Key: 53661547
• Report Number: 9612164-2016-00930
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2018
• Device Catalogue Number: RSINT35009X
• Device Lot Number: 0007985496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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: 52 YR
• Patient Weight: 76