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

Model Number 10672

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: p elite ous mr 16 x 2.50mm stent delivery system was returned for analysis with the product mandrel inserted and stent protector covering half the stent.The mandrel was stuck on the device, but the proximal half of stent was visibly damaged.The device was placed in a bath to soak, and when removed the mandrel, and stent protector were able to be removed without issue.A visual examination of the stent found signs of stent damage.Stent struts in the mid-section of the stent were lifted and pulled in all directions.The undamaged stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and issues were noted.The proximal balloon cone was unfolded and balloon was noted to be lifted and pulled underneath the area of stent damage.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found a kink 450mm distal to the distal end of the strain relief.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.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 25sep2020.It was reported that shaft kink and crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 85-90% stenosed target lesion was located in the severely tortuous and non-calcified right coronary artery.A 16 x 2.50 promus elite mr drug-eluting stent was advanced but failed to cross the lesion.The physician tried to cross several times, but still failed to cross, and the shaft was kinked.The procedure was completed with a different device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a 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: 10680214
• MDR Text Key: 211364802
• Report Number: 2134265-2020-13764
• 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: 10/14/2020

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: 09/02/2021
• Device Model Number: 10672
• Device Catalogue Number: 10672
• Device Lot Number: 0024418401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2019
• 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