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

Model Number 10673

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

A promus elite ous mr 20 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found the mid and proximal struts were lifted from their crimped position.The undamaged stent was measured and the result was within the 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 showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.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

Reportable based on device analysis completed on 11sep2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via the right femoral artery.The 90% stenosed, 18 x 3.00mm, concentric, de novo target lesion containing a bend of between greater than 45 and less than 90 degrees was located in the severely tortuous and mildly calcified left anterior descending artery.Pre-dilatation was performed with a 9 x 2.50mm maverick 2 balloon catheter resulting in 70% stenosis.A 20 x 3.00 promus elite drug-eluting stent was then advanced but failed to cross the lesion.The device was removed and multiple pre-dilatations were performed but the stent still failed to cross.The procedure was completed with a 18 x 3.00mm non-boston scientific stent.No patient complications were reported and the patient was stable.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS ELITE
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10617532
• MDR Text Key: 209592109
• Report Number: 2134265-2020-12951
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: 10673
• Device Catalogue Number: 10673
• Device Lot Number: 0025072364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• 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
• Treatment: GUIDE CATHETER: 7F JL 3; GUIDEWIRE: SION BLUE
• Patient Age: 50 YR
• Patient Weight: 65