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

Catalog Number RSINT22518X

Device Problems Migration or Expulsion of Device (1395); Inaccurate Delivery (2339)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/28/2016

Event Type  Injury  

Event Description

After probing the tci with a al-1 guide catheter to give better support, two guide wires were placed in the patient, one distally in the ada and the other in the distal acx.Patient was on full heparin.The lesion was pre-dilated with a 2x30 balloon to 18 atms, middle segment stenosis progressed.It was reported that the physician was attempting to advance a resolute integrity drug eluting stent in a mid segment artery during stent delivery the device was inflated to 16atm.When the physician withdrew the stent catheter, it was reported that the stent moved towards the proximal area in the vessel.It was reported that the resolute stent was positioned in a different place than intended.The proximal are of the vessel was pre-dilated and a non-mdt stent was then implanted at 18 atms to overlap and fix the resolute stent in place.On review it was noted that there was irregularities overlapping in this area so post dilatation was carried out with an nc balloon to 17 atms.Review showed a good result (stenosis treated with distal bed diffusely diseased but improved distal flow).

Manufacturer Narrative

Device evaluation: there was no damage visible to the delivery system catheter.(b)(4).

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: 5708046
• MDR Text Key: 46854913
• Report Number: 9612164-2016-00527
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2017
• Device Catalogue Number: RSINT22518X
• Device Lot Number: 0007517974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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: 68 YR