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

Model Number 10665

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that balloon removal difficulty occurred.The stenosed target lesion was located in the mildly tortuous and mildly calcified proximal right coronary artery.A 24 x 4.00 promus premier select stent was advanced for stent placement.The stent was successfully implanted with 20 atmospheres and the physician deflated the balloon twice; however, when attempting to retreat the balloon through the guide, it was difficult to remove.To resolve this, the whole system was removed (the wire, the balloon, and the guide).The devices were removed and the procedure was completed with the original stent that was implanted.No complications were reported, and the patient was in good condition post-procedure.

Event Description

It was reported that balloon removal difficulty occurred.The stenosed target lesion was located in the mildly tortuous and mildly calcified proximal right coronary artery.A 24 x 4.00 promus premier select stent was advanced for stent placement.The stent was successfully implanted with 20 atmospheres and the physician deflated the balloon twice; however, when attempting to retreat the balloon through the guide, it was difficult to remove.To resolve this, the whole system was removed (the wire, the balloon, and the guide).The devices were removed and the procedure was completed with the original stent that was implanted.No complications were reported, and the patient was in good condition post-procedure.

Manufacturer Narrative

Correction to h6: removal of coding inadvertently added additional information in d4: batch number.

Event Description

It was reported that balloon removal difficulty occurred.The stenosed target lesion was located in the mildly tortuous and mildly calcified proximal right coronary artery.A 24 x 4.00 promus premier select stent was advanced for stent placement.The stent was successfully implanted with 20 atmospheres and the physician deflated the balloon twice; however, when attempting to retreat the balloon through the guide, it was difficult to remove.To resolve this, the whole system was removed (the wire, the balloon, and the guide).The devices were removed and the procedure was completed with the original stent that was implanted.No complications were reported, and the patient was in good condition post-procedure.

Manufacturer Narrative

Correction to h6: removal of coding inadvertently added additional information in d4: batch number.Device evaluated by manufacturer: a visual, tactile, microscopic examination, functional testing and device to device interaction testing was performed on the returned device.Device analysis confirmed that the device was inserted through a guide catheter.A detailed microscopic examination of the distal extrusion identified clear evidence of excessive tensile force having been applied to the shaft.The extrusion was stretched down just distal to the guidewire exit port.Due to the stretching evident distal to the wire port, it was not possible to inflate the balloon in order to try and deflate and achieve a better refold in the balloon material in order to facilitate the withdrawal of the device from the guide.A microscopic examination of the balloon identified no evidence of a tear in the balloon material, however it was noted that the balloon was not refolded.Initial attempts to withdraw the device from the guide catheter failed.However, using force it was possible remove the device from the guide catheter.No other damages were noted along the entire device.The difficulties encountered were consistent with the fact that the balloon was not refolded.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17312288
• MDR Text Key: 319017416
• Report Number: 2124215-2023-36729
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2023

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 Model Number: 10665
• Device Catalogue Number: 10665
• Device Lot Number: 0030732575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 08/24/2023
• Supplement Dates FDA Received: 07/19/2023; 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• 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