MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Model Number INT35015UX

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute integrity rx coronary, drug eluting stent was used during a procedure to treat a none tortuosity, severely calcified lesion exhibiting 98-99% stenosis in the right coronary artery (rca).There was no damage noted to the packaging.The device was removed from the hoop with no issues.The device was inspected with no issues.Negative prep was not performed.The device did not pass through a previously deployed stent.It was reported that a patient experiencing severe chest pain with diagnosis of stemi inferiorly with reciprocal changes was brought from er to the cath lab for evaluation and treatment.A diagnostic coronary angiography shows 98-99% occluded rca secondary to plaque rupture.A resolute integrity bare metal stent was placed in the right coronary artery with good results and prompt resolution of symptoms.It was reported that the product was expired.The expired product was quarantined within the cath lab, however was still accessible to staff.Staff pulled an expired bms from quarantined pile for implant.Note, routine inventory inspection by mdt rep have been restricted due to covid-19 allowing no access to the hospital starting march 2020.The patient is alive with no injury.

Manufacturer Narrative

Additional information: there was no medical/surgical intervention as a result of the event.Correction: an integrity rx coronary, drug eluting stent was used.Pma/510k # updated 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: INTEGRITY RX
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10128159
• MDR Text Key: 194319032
• Report Number: 9612164-2020-02136
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 00613994798565
• UDI-Public: 00613994798565
• Combination Product (y/n): N
• PMA/PMN Number: P030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2020
• Device Model Number: INT35015UX
• Device Lot Number: 0009149091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 76