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

Catalog Number RSINT22512UX

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The physician used a resolute integrity rx drug-eluting stent to treat a moderately tortuous and moderately calcified lesion exhibiting 95% stenosis in the proximal obtuse marginal.The device was removed from its packaging per ifu and inspected with no issues noted.Negative prep was performed with no issues identified.Resistance was encountered advancing the device and excessive force was used during delivery.The stent was deployed, but not evenly (cylindrically) as there was a ' chunk of calcium in the middle' and the stent did not sufficiently expand prior to attempting removal of the balloon.It was reported that difficulties were encountered removing the balloon following stent deployment.Sufficient time was given to allow the balloon to fully deflate prior to attempting removal.After multiple inflations and aggressive removal, the balloon was successfully removed from the patient.Balloon and guide wire had to be removed at the same time.No damage noted to the guidewire.No deformation was noted to the stent.No patient injury was encountered and artery is patent.

Manufacturer Narrative

Device evaluation: the device returned with the stopcock still attached to the luer of the device.The device returned with the stent not present on the device as the stent was deployed in the vessel.The distal tip was slightly flared.The balloon of the resolute integrity device showed evidence of previous inflation and appeared to have been deflated sufficiently.There was evidence of crimp impressions along the balloon working length.

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: 5249516
• MDR Text Key: 32263273
• Report Number: 9612164-2015-01780
• 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,Followup
• Report Date: 11/25/2015

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 Expiration Date: 05/07/2016
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0007359548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided; 11/25/2015
• Supplement Dates FDA Received: 12/03/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• 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