MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

Model Number 10674

Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - over the age of 18 years old.

Event Description

It was reported that mislabeling occurred.A 24 x 2.75 promus elite mr drug-eluting stent was selected for treatment.It was observed that the 24 x 2.75 promus elite mr was mislabeled.The procedure was completed with a 24 x 2.24 promus elite.There were no patient complications reported.

Manufacturer Narrative

A2: age at time of event - over the age of 18 years old.

Event Description

It was reported that mislabeling occurred.A 24 x 2.75 promus elite mr drug-eluting stent was selected for treatment.It was observed that the 24 x 2.75 promus elite mr was mislabeled.The procedure was completed with a 24 x 2.24 promus elite.There were no patient complications reported.It was further reported that the device box was not incorrectly labeled; however, the device did not match the label.

Manufacturer Narrative

A2: age at time of event: over the age of 18 years old.Correction to h6 device codes.Initially reported as device markings/labelling problem a2101 corrected to adverse event without identified device or use problem a24.

Event Description

It was reported that mislabeling occurred.A 24 x 2.75 promus elite mr drug-eluting stent was selected for treatment.It was observed that the 24 x 2.75 promus elite mr was mislabeled.The procedure was completed with a 24 x 2.24 promus elite.There were no patient complications reported.It was further reported that the device box was not incorrectly labeled.The physician underestimated the the size of the stent required to complete the procedure and decided to change for another size.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12681236
• MDR Text Key: 277918729
• Report Number: 2134265-2021-13308
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: 10674
• Device Catalogue Number: 10674
• Device Lot Number: 0026653417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 10/24/2021; 02/07/2022
• Supplement Dates FDA Received: 11/23/2021; 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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 Sex: Male