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

Catalog Number	RSINT22514UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the delivery system was returned for analysis.Delivery system was returned covered in blood, inside and outside.The delivery system was returned with a detachment on the hypotube; 49.1cm proximal to the distal tip.Hypotube was badly stretched and kinked on the distal end of the detachment site.The hypotube material was oval and jagged on the distal side of the detachment site.Support wire was on show at detachment site.(b)(4).
Event or Problem Description
It was reported that during use of a resolute integrity device, the device detached during removal.The device was removed from packaging and hoop with no damage noted.Device was prepped with no issues noted.The physician was employing a kissing balloon technique using the resolute integrity, a medtronic 6fr launcher and a non mdt balloon device.Two lesions were being treated in the obtuse marginal (diagonal branch).Lesion1 was non tortuous and mildly calcified, lesion 2 was mildly tortuous and mildly calcified.Both lesions had 70% stenosis.It was reported that the resolute integrity was being placed in lesion 1 and a non mdt balloon device in lesion 2.The device was not kinked and re-straightened during use.The device did not pass through a previously-deployed stent.While physician was doing the kissing balloon in the medtronic 6fr launcher, resistance was encountered when advancing the device however no excessive force was used.The stent was successfully implanted in the target lesion.Physician felt resistance when pulling back the devices into the guide and that is when he removed everything.The stents catheter was in two pieces (stent was already deployed previous to this) and the balloon on the non mdt device was all mangled.It was in the guide and they removed everything.The broken pieces were removed from the patient without intervention.The detached portion does not remain in patient.There was no injury to patient or clinical sequelae.
Additional Manufacturer Narrative
Additional information: it is reported that the nc euphora balloon catheter became tangled with the non-mdt balloon during the procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6940381
• Report Number: 9612164-2017-01449
• Device Sequence Number: 873346
• Product Code: NIQ
• UDI-Device Identifier: 00643169037410
• UDI-Public: 00643169037410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: RSINT22514UX
• Device Lot Number: 0008448804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR