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

Model Number 9392

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: promus element plus,mr,ous 2.50x32mm stent delivery system (sds) was returned for analysis with a pigtail mandrel inserted in the tip and inside the stent protector.A visual examination of the stent found stent damage with struts in the middle region lifted from the crimped position.The undamaged stent outer diameter was measured using a snap gauge and the result was within maximum crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube found no issues.A examination of the shaft polymer extrusion found no issues.An examination of the tip found tip damage with a pigtail mandrel inserted and stuck in the tip of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 21-sep-2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via radial artery.The 90% stenosed, 2.5mm x 26mm, eccentric, de novo target lesion containing a >45 to <90 degrees bend was located in the moderately tortuous and mildly calcified mid left circumflex coronary artery.A 2.50x32mm promus element plus drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS ELEMENT PLUS
• 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: 10648781
• MDR Text Key: 210418074
• Report Number: 2134265-2020-13897
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Model Number: 9392
• Device Catalogue Number: 9392
• Device Lot Number: 0023770064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• 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