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

Lot Number 0025812233

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: promus elite us mr 32 x 2.50mm stent delivery system was returned for analysis.A visual examination of the stent found proximal stent damage with the struts pulled in a distal direction.The undamaged crimped stent outer diameter was measured and the result is maximum crimped stent profile measurement.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 no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found bunching/accordioning of the inner shaft polymer extrusion 138.2cm distal to the distal end of strain relief.An attempt was made to load test guidewire however when the tip of the guidewire reached the damage in the inner shaft polymer extrusion it could not advance further.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 22-dec-2020.It was reported that tracking difficulties occurred.A 32 x 2.50 promus elite drug-eluting stent was selected for use with a.014 x 300 cm non-boston scientific guide wire but it could not load onto the wire.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11090821
• MDR Text Key: 224395010
• Report Number: 2134265-2020-18533
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Lot Number: 0025812233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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