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

Model Number 10666

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.Vascular access was obtained via radial artery.A 90% stenosed, eccentric, de novo target lesion containing >45 and <90 degrees bend was located in the moderately tortuous and moderately calcified mid right coronary artery (rca).An unknown drug-eluting stent (des) was implanted in the proximal rca.After using a non- boston scientific (bsc) guide catheter, a non-bsc guide wire was advanced to the distal rca.Subsequently, a 28x3.50mm promus premier select des was advanced to treat the lesion in the mid rca.However, the device was caught in plaque distal to proximal des.Several attempts were conducted to pull out the device but was unsuccessful.The device was inflated and was implanted at the site where it can not be moved forward or backward.A non-bsc stent was advanced to the mid rca and was successfully implanted.The procedure was completed with no patient complications reported.The patient status was stable.

• Brand Name: PROMUS PREMIER SELECT
• 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: 14246123
• MDR Text Key: 290374526
• Report Number: 2134265-2022-04880
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: ID
• 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
• Report Date: 04/28/2022

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: 10/04/2023
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0028183122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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 Age: 58 YR
• Patient Sex: Male