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

Model Number H7493918438270

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2016

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the complaint device was returned for analysis.No manifold returned.A visual and tactile examination of the device found that hypo tube was broken 1066 mm proximal to the midshaft bond with multiple kinks along the full catheter length.Kink 60 mm distal to mid shaft bond on mid shaft and a kink at the port skive.No issues inner or outer polymer extrusion.The crimped stent, balloon sections of the device were visually and microscopically examined and stent strut rows 6 to 10 and 13 from the proximal end of stent were pushed and deformed.Stent strut rows 7 to 10 from the distal end of the stent were pushed and deformed.No issues were noted with balloon.The tip was visually and microscopically examined and no issues were noted.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 device analysis completed on 08-dec-2016.  it was reported that crossing difficulties were encountered.    the 80% stenosed target lesion was located in the highly calcified right coronary artery (rca).A 6f jr 3.5 guide catheter was engaged, followed by a non-bsc guide wire was advanced, then pre-dilatation was done with a non-bsc balloon catheter.Subsequently, a 2.75x38mm promus element¿ plus stent was advanced but failed to cross the target lesion.Pre-dilatation was performed again at higher pressure and the procedure was completed with another with same device.No patient complications were reported and the patient's status was stable.  however, returned device analysis revealed stent damaged and hypotube break.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 6196592
• MDR Text Key: 63067575
• Report Number: 2134265-2016-11932
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2016
• Device Model Number: H7493918438270
• Device Catalogue Number: 39184-3827
• Device Lot Number: 18093861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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
• Treatment: 6F JR 3.5 GUIDE CATHETER; FIELDER WIRE
• Patient Age: 56 YR
• Patient Weight: 81