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

Model Number 10668

Device Problem Material Rupture (1546)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified proximal left anterior descending (lad) artery.A 38 x 3.50 promus premier select drug-eluting stent was deployed for treatment.The stent was inflated at 10 atmospheres and dyed hanging noted in diagonals.The stent balloon was removed outside in a deflated state; however, a pinhole in the mid part of the stent balloon was noticed.The procedure was completed with the same stent opposed with nc balloon.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: promus select ous mr 38 x 3.50mm stent delivery system, catheter was returned for analysis.The stent was deployed from the balloon and was not returned for analysis.A visual and microscopic examination of the balloon material identified no tears or holes in the balloon.There was a large build-up of solidified blood inside the balloon.The device was attached to an encore inflation unit and during an attempt to inflate the balloon, a pinhole leak was confirmed in the mid-section of the balloon.A microscopic examination of the leak site could not identify any issues with the balloon material which could have contributed to the pinhole leak.A visual and microscopic examination of the proximal markerband found no issues.An examination of the tip identified no damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.

Event Description

It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified proximal left anterior descending (lad) artery.A 38 x 3.50 promus premier select drug-eluting stent was deployed for treatment.The stent was inflated at 10 atmospheres and dyed hanging noted in diagonals.The stent balloon was removed outside in a deflated state; however, a pinhole in the mid part of the stent balloon was noticed.The procedure was completed with the same stent opposed with nc balloon.No patient complications were reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15860661
• MDR Text Key: 307586973
• Report Number: 2124215-2022-48011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10668
• Device Catalogue Number: 10668
• Device Lot Number: 0029411683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Race: Asian