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

Catalog Number ERES25030X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An attempt was made to use one endeavor resolute rx coronary drug eluting stent to treat a moderately tortuous and calcified lesion exhibiting 100% total chronic occlusion located in the distal rca.The device was inspected with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during delivery to/at the lesion.The dislodged stent was removed by surgery.The patient is reported to be alive with no injury.

Manufacturer Narrative

An image of the device shelf carton was received for analysis.A photograph of the complaint device in a plastic bag was received.It appears as though there is no stent on the delivery system , though it is not possible to definitively tell due to the quality of the image.No other deformation is visible to the device.The device was returned for evaluation.The stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: no excessive force was used.Negative prep was performed.The device did not pass through a previously deployed stent.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: 8102104
• MDR Text Key: 128286156
• Report Number: 9612164-2018-03348
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: ERES25030X
• Device Lot Number: 0008991649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 12/03/2018; 01/10/2019
• Supplement Dates FDA Received: 12/17/2018; 01/16/2019
• Date Device Manufactured: 02/12/2018
• 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: 57 YR
• Patient Weight: 67