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

Model Number H7493911338300

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

Same case as mdr id # 2134265-2014-08267.Reportable based on analysis completed on (b)(4) 2014.It was reported that crossing difficulties and hub damage occurred.  vascular access was obtained via the right femoral artery.The 30mm in length target lesion was located in the moderately calcified and moderately tortuous and 3mm in diameter left anterior descending (lad) artery.The lesion contained a <=45 degrees bend.The lesion was predilated using balloons up to 2.5x10mm.A 3.00x32mm promus element ¿ stent delivery system (sds) was selected; however the device was unable to cross the lesion and it was noted that the hub of the sds was broken.This was exchanged with another 3.00x38mm promus element ¿ long sds ; however, the device still failed to cross the lesion and the hub was also broken.The procedure was completed with a 3.0x38mm non-bsc stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break.

Manufacturer Narrative

Age at time of event: 18 years or older.Device is combination product.(b)(4).Device evaluated by mfr: the stent delivery system was returned for analysis.A visual and tactile examination found multiple kinking on the hypotube shaft and the shaft itself was broken at the point of a severe kink.The hypotube broke 256mm distal from the strain relief.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the stent, the outer and mid-shaft section found no issues with their profile.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).

• Brand Name: PROMUS ELEMENT ? LONG
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4418440
• MDR Text Key: 5164558
• Report Number: 2134265-2014-08328
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2015
• Device Model Number: H7493911338300
• Device Catalogue Number: 39113-3830
• Device Lot Number: 16983522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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