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

Device Problem Inaccurate Delivery (2339)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician was intending to use a resolute integrity device to treat a lesion in the mid to distal lm coronary artery.The vessel was non tortuous with mild calcification and exhibited 10% stenosis.No abnormalities were reported in relation to the patient¿s anatomy.No damage was noted to the packaging.No issues were noted when removing the device from the hoop/tray or when removing the protective sheath.The device was inspected and negative prep was performed with no issues noted.The lesion was pre-dilated.Resistance was encountered when advancing the device but no excessive force was used.The physician was stenting the lad with a resolute device of a different size.Upon inflation the delivery system moved due to the patients heavy breathing.The physician ended up stenting a little into the left main.It was reported that some of the stent was hanging out.The physician flared the end of the stent and ballooned the proximal end of the circ with an sc balloon and then attempted to stent the circ.Upon entering the circ with the stent it was reported that the physician felt resistance and pulled the delivery system back.The inflation de vice remain on neutral pressure during delivery of the device.Upon removal he noticed that the stent was no longer on the balloon and was in the left main.The physician attempted to snare the stent with multiple sized snares and also attempted to wire the stent and inflate a balloon distally to it to try and catch it and bring it back to the guide.All attempts were unsuccessful and the physician then proceeded to crush the stent in the left main.The physician then stented the circ and the left main with 2 more resolute devices.Ivus was performed and it showed good opposition of the stents and minimal narrowing where the stent was crushed.Patients as of today is doing fine.

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: 6560338
• MDR Text Key: 74937271
• Report Number: 9612164-2017-00580
• 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,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• 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