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

Model Number 10672

Device Problems Deflation Problem (1149); Leak/Splash (1354)

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

Event Date 06/23/2023

Event Type  malfunction  

Event Description

It was reported that deflation issue occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 16 x 3.50 promus elite drug-eluting stent was advanced for treatment.However, during the procedure, the stent balloon had a leak and was not inflating and deflating properly.The device was removed, and the procedure was completed with a 16 x 3.00 promus elite drug-eluting stent with timi 3 flow.No patient complications were reported.

Manufacturer Narrative

The promus elite ous mr 16 x 3.50mm was returned for analysis.Visual and tactile examination revealed no kinks or damage to the hypotube shaft profile or shaft polymer extrusion.Microscopic inspection of the shaft polymer extrusion profile revealed a pinhole lead in the distal extrusion and no damage to the inner/wire lumen at the site of the pinhole leak.The leak appeared to be a puncture in the outer lumen.No issues were identified with the lumen which could have contributed to the leak.A microscopic examination of the stent found no damage; the stent was securely crimped to the balloon.A microscopic examination of the top section found on damage.Leakage testing revealed a pinhole leak located 5.4cm from the tip of the device on the polymer extrusion.As a result of the leak, the balloon could not inflate properly and as a result just the proximal stent struts started to partially deploy.

Event Description

It was reported that deflation issue occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 16 x 3.50 promus elite drug-eluting stent was advanced for treatment.However, during the procedure, the stent balloon had a leak and was not inflating and deflating properly.The device was removed, and the procedure was completed with a 16 x 3.00 promus elite drug-eluting stent with timi 3 flow.No patient complications were reported.

• Brand Name: PROMUS ELITE
• 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: 17309106
• MDR Text Key: 319378965
• Report Number: 2124215-2023-34732
• 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
• Report Date: 10/06/2023

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: 10672
• Device Catalogue Number: 10672
• Device Lot Number: 0030769884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Race: Asian