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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fistula (1862); Hemorrhage/Bleeding (1888); Neuropathy (1983); Renal Failure (2041); Cardiac Tamponade (2226); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Journal: wiley title: comparative safety of biodegradablepolymer everolimus-eluting, durable-polymer everolimus-eluting, and durable-polymer zotaro limuseluting stents in contemporary clinical practice.Reference: doi.Org/10.1002/ccd.28864 there is no established or suspected causal relationship between the device and the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.Date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study ¿comparative safety of biodegradablepolymer everolimus-eluting, durable-polymer ev erolimus-eluting, and durable-polymer zotarolimus eluting stents in contemporary clinical practice¿.53,724 patients were included in the study.Resolute integrity coronary drug eluting stents were among a number of drug eluting stents used in this study for comparable safety.Clinical events of stroke and stent thrombosis were reported in the population.It was stated that 2-year post-discharge mortality and in-hospital mortality occurred.It was also noted that there was no difference in 2-year post discharge mortality between resolute integrity and the other stents used.

Manufacturer Narrative

Additional information: the objective of this study was to determine the outcomes of patients treated with bioabsorbable polymer everolimus-eluting, durable polymer everolimus-eluting, or durable polymer zotarolimus-eluting stents in routine clinical practice.Clinical events of death, stent thrombosis, stroke, perforation, tamponade, new requirement for dialysis, transfusion requirement and vascular complications including pseudoaneurysm, arterio-venous fistula, femoral neuropathy, retroperitoneal hematoma, acute thrombosis, surgical repair, loss of limb, or hematoma were reported in the population.A2: average age a3: majority gender a5: majority race b7: relevant history added full journal article text received, see publication details below: journal article: comparative safety of bioabsorbable polymer everolimus-eluting, durable polymer everolimuseluting, and durable poly mer zotarolimus-eluting stents in contemporary clinical practice authors: nadia r.Sutton, milan seth, ryan d.Madder, devraj sukul, simon r.Dixon, louis a.Cannon, hitinder s.Gurm journal: circ cardiovasc interv.Year: 2021 reference: doi: 10.1161/circinterventions.120.00985 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 10499538
• MDR Text Key: 207730677
• Report Number: 9612164-2020-03368
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR