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

Catalog Number ERES40018X

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 02/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient was admitted for progressive chest pain.Four years ago, the patient had surgical aortic valve replacement (savr), and preoperative multislice computed tomography (msct) showed no coronary stenosis.A year after savr, the patient presented with chest pain, and coronary angiogram revealed an isolated ostial left main coronary artery (lmca) stenosis.A 4.0 mm × 18.0 mm medtronic stent was implanted without a high-pressure postdilation.The patient was discharged on aspirin, ticagrelor (replaced with clopidogrel after 3 months), and statins.Unfortunately, the stent was found to protrude into the aorta by approximately 10 mm by msct at 4-month follow-up.During this admission, the patient underwent nonselective coronary angiography due to the previous excessively protruding stent and showed in-stent restenosis (isr) at ostial lmca.It was almost impossible to place a guidewire through ostium to center lumen of previous stent in this context.A non-medtronic guidewire via the nonengaged jl4.0 (6f) medtronic guiding catheter was attempted to advance into distal left anterior descending through side strut of previous stent, which was confirmed by intravascular ultrasound (ivus).A 2.0 mm × 15.0 mm sprinter semicompliant balloon was positioned to the side strut and inflated at 8 atm with caution incase of strut deformation and then deposited to the isr and inflate at 10¿14 atm.Optical coherence tomography (oct) was performed and found focal and concentric fibrous intimal hyperplasia with stent malapposition at ostial lmca.A 4.0 mm × 18.0 mm non-medtronic stent was deployed following by a 4.0 mm × 12.0 mm sprinter noncompliant balloon inflate at 16 atm.Subsequent oct confirmed good stent expansion without strut malapposition, while ivus showed the proximal segment of the new stent protruded approximately 7 mm into the aorta.Thus, two stents exaggeratedly protruding from the lmca into the aorta were observed by postoperative msct.The patient was asymptomatic on aspirin and ticagrelor, and both stents remained at good patency at 1-year msct follow-up.

Manufacturer Narrative

It was reported that the medtronic stent was placed improperly, and the stent was selected too long.It was reported that a technical problem of the technician caused the stent to be narrow, and was not related to a quality problem for the medtronic stent.The patient was in a good condition after the procedure.It was reported that none of the adverse events that were mentioned within the article were related directly to medtronic devices.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDEAVOR RESOLUTE 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: 8304754
• MDR Text Key: 134993115
• Report Number: 9612164-2019-00416
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160043:
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2016
• Device Catalogue Number: ERES40018X
• Device Lot Number: 0007217148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2019
• Date Device Manufactured: 07/08/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR