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

Device Problems Material Distortion (2977); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: date article was accepted.Journal article: contribution of optical coherence tomography imaging in management of iatrogenic coronary dissection.N.Barber-chamoux et al./ cardiovascular revascularization medicine 17 (2016) 138¿142 cardiovascular revascularization medicine 17 (2016) 138¿142 http://dx.Doi.Org/10.1016/j.Carrev.2016.01.009 1553-8389/© 2016 elsevier inc.All rights reserved.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician decided to treat a cto lad artery with a resolute integrity drug eluting stent.One month later, during a myocardial tomoscintigraph prompted by the reoccurrance of angina, apical ischemia was shown.Angiograph showed a previously unnoticed dissection at the distal end of the previously implanted stent with a plaque rupture inducing stenosis.Under expansion of the stent due to fibrocalcific plaque.Angioplasty was carried out with 2 stents implanted with post dilatation of the proximal stent.Final acquisitions show a good result of stent apposition with a non-compressive distal edge dissection for a diameter less than 2 mm.The one-year follow-up does not show any angina recurrence.

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: 5708060
• MDR Text Key: 46855093
• Report Number: 9612164-2016-00524
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110013
• 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
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 05/10/2016
• 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