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

Model Number 9394

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: promus element plus,mr,ous 2.50x38mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Mid to proximal stent struts lifted.The undamaged stent outer diameter was measured and the result is 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 multiple kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 01-jul-2020.It was reported that advancing difficulties were encountered.The target lesion was located in the severely tortuous and calcified left circumflex artery.A 2.50x38mm promus element plus drug-eluting stent was advanced, but could not reach the lesion even after several attempts.The procedure was completed with another of same device.There were no patient complications reported and the patient 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: 10289755
• MDR Text Key: 199293279
• Report Number: 2134265-2020-08988
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: 9394
• Device Catalogue Number: 9394
• Device Lot Number: 0022771833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 64