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

Model Number 9382

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: promus element plus,mr,ous 2.25x12mm stent delivery system was returned for analysis.Red blood like substance was visible in the inflation lumen of the distal shaft and in the balloon.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured and the result was within max 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 distal tip damage.A visual and tactile examination of the hypotube shaft found a kink 147mm 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 a tear noted at the wire exchange port, extending distally, 9mm in length, tear was in the inner and outer.Attempted to load the device over an.014 inch guidewire in preparation for leak test however the guidewire was blocked.The device was placed in a water bath to soak at 37c to soften any dried blood or media in the wire lumen that may have been blocking the wire.The device was removed from the bath and attempted to load the device over an 0.014 inch guidewire in preparation for leak test; loaded without issue.Leakage test was carried out and pressure was applied using water and encore inflation device (to rbp 18atm).A leak was noted at the shaft tear site, the device did not hold pressure, and the balloon did not inflate.Note: encore inflation device verified before and after use.No other issues were identified during analysis.

Event Description

Reportable based on device analysis completed on 03jun2020.It was reported that balloon leak occurred.The target lesion was located in the severely calcified left circumflex artery.A 2.25x12mm promus element plus drug-eluting stent was advanced for treatment; however, it was noted that the device was leaking liquid.The procedure was cancelled.There were no patient complications reported and the patient was stable.However, returned device analysis revealed shaft tear.

• 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: 10189754
• MDR Text Key: 196271851
• Report Number: 2134265-2020-07621
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: 9382
• Device Catalogue Number: 9382
• Device Lot Number: 0022709212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2018
• 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: 69 YR
• Patient Weight: 75