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

Model Number H7493911316270

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the manifold/hub of the stent delivery system (sds) was not returned for analysis therefore it was not possible to identify the catheter batch/serial number.A visual examination of the stent found that stent struts from rows 2 to 16 from the proximal end of stent were deformed, bent and twisted.Stent damage most likely occurred during withdrawal attempts.The bumper tip of the device showed no signs of damage.The balloon body was reviewed and no issues were noted with the overall balloon; however the balloon appeared bent at the location where stent damage was noted, from stent struts rows 2 to 16 from the proximal end of stent.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The type of damage noted most likely occurred due to stent damage.A visual and tactile examination found that hypotube was broken 1444mm from edge of the tip with multiple kinks along the full catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues on the extrusion.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 device analysis completed on 07-dec-2016.It was reported that crossing difficulties were encountered.   the target lesion was located in the distal left anterior descending artery.After cannulating the left side using a 6f non-bsc introducer sheath, a 0.014 guide wire was advanced.Following pre-dilation using a balloon catheter, a 2.75x16mm promus element ¿ drug eluting stent was advanced but failed to cross the lesion.The device was completely removed.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break and stent damage.

• Brand Name: PROMUS ELEMENT ¿
• 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: 6198983
• MDR Text Key: 63211558
• Report Number: 2134265-2016-11848
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: SIMILAR
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2016
• Device Model Number: H7493911316270
• Device Catalogue Number: 39113-1627
• Device Lot Number: 18144694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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
• Patient Age: 62 YR