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

Catalog Number RSINT25014UX

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to a resolute integrity drug eluting stent to treat a lesion located in the proximal ramus.No damage was noted to packaging and no issues were noted when removing the device from the hoop/tray.The device was inspected with no issues.Resistance was not encountered when advancing the device and excessive force was not used during delivery.The device did not pass through a previously deployed stent.It was reported that the stent was deployed in proximal ramus without issue.After the ramus stent was placed the physician attempted to wire the circumflex artery.The non-medtronic coronary wire became stuck to proximal end of stent that was placed in the ramus.The physician stated he used a lot of force to try and remove the wire but each time he pulled, the guide catheter was being pulled into the ramus.The wire eventually pulled free and the physician was able to place the wire down the circumflex.While working on placing a stent into the circumflex they noticed the ramus stent was no longer in place.The stent was never found after looking under fluoroscopy and inspecting the guides and wires used.The product was replaced by another resolute integrity device of the same size.No intervention was reported.No patient injuries reported.

• 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: 7208854
• MDR Text Key: 98013906
• Report Number: 9612164-2018-00115
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSINT25014UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• 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