MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ LONG; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911338250

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is combination product.(b)(4).Device evaluated by mfr: promus element mr ous 2.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent strut rows 23, 24, 30, 31 and 32 from the proximal end of the stent were damaged and deformed.The undamaged section of the crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The bumper tip of the device was examined and no issues were noted.The balloon body was reviewed and no issues were noted with the overall balloon.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 along the full catheter length.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on analysis completed on 22-mar-2017.It was reported that a shaft kinked occurred.The 80% stenosed, 38 x 2.5 mm target lesion was located in the severely tortuous and severely calcified left circumflex (lcx) artery.A 2.50 x 38 mm promus element ¿ long drug-eluting stent was advanced to treat the lesion.However, the delivery shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS ELEMENT ¿ LONG
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6463298
• MDR Text Key: 72208092
• Report Number: 2134265-2017-03069
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: SIMILAR
• 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: 03/22/2017

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: 08/31/2017
• Device Model Number: H7493911338250
• Device Catalogue Number: 39113-3825
• Device Lot Number: 19012588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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