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

Lot Number 0030316295

Device Problem Entrapment of Device (1212)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that catheter entrapment on guidewire occurred.A 12 x 3.00 promus elite drug-eluting stent (des) was advanced for treatment.However, during insertion, the promus device got tangled up with a non-boston scientific (bsc) guidewire.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: p elite us mr 12 x 3.00mm was returned for analysis with a bent pig tail mandrel in wire lumen, and with its stent protector on.The device was returned with a segment of customer guidewire inserted.This segment of guidewire was removed without issue.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip found no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found the polymer extrusion bunched and kinked in multiple locations along the length of it, for this reason it was impossible to remove the guidewire attached.Could not remove the customer guidewire due to the extent of the polymer shaft damage.No other issues were identified during the product analysis.

Event Description

It was reported that catheter entrapment on guidewire occurred.A 12 x 3.00 promus elite drug-eluting stent (des) was advanced for treatment.However, during insertion, the promus device got tangled up with a non-boston scientific (bsc) guidewire.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17012398
• MDR Text Key: 316208147
• Report Number: 2124215-2023-24860
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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: 04/02/2024
• Device Lot Number: 0030316295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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