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

Model Number 10661

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported that balloon deflation and removal difficulty occurred.A 8 x 4.00 promus premier select stent was advanced to the target lesion.The promus premier select balloon could not be opened and deflated.The promus premier select balloon was opened an unknown number of times to 6-8 bar and deflated afterwards.The promus premier select balloon was able to be removed from the patient, but only with force applied.The procedure was completed with another 8 x 4.00 promus premier select stent.There were no patient complications.

Event Description

It was reported that balloon deflation and removal difficulty occurred.A 8 x 4.00 promus premier select stent was advanced to the target lesion.The promus premier select balloon could not be opened and deflated.The promus premier select balloon was opened an unknown number of times to 6-8 bar and deflated afterwards.The promus premier select balloon was able to be removed from the patient, but only with force applied.The procedure was completed with another 8 x 4.00 promus premier select stent.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr.: a visual, tactile and microscopic examination was performed on the returned device.Device analysis identified multiple kinking along the hypotube.A break was confirmed in the distal extrusion.The extrusion was stretched along both sections of the break.An examination of the balloon identified that the balloon had been inflated and was not refolded.The stent had deployed/detached from the balloon and was not returned with the device.As no reported shaft break or stent dislodge was reported during the procedure, it is likely that the stent may have been deployed following the balloon inflations and the break may have occurred during device handling, post procedure.

• 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: 17337829
• MDR Text Key: 319217195
• Report Number: 2124215-2023-37643
• 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
• Report Date: 09/05/2023

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 Expiration Date: 02/07/2024
• Device Model Number: 10661
• Device Catalogue Number: 10661
• Device Lot Number: 0028855297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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