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

Model Number H7493911338270

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(6).(b)(4).Device evaluated by mfr: promus element mr ous 2.75 x 38mm stent delivery system was returned for analysis.A visual examination of the stent revealed damage.Proximal struts 1 and 2 were pulled in a proximal direction.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The bumper tip of the device was examined and no issues were noted.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.The balloon was inflated to rated burst pressure.The stent deployed without issue.The balloon deflated in 8 seconds and is within the specification.A visual and tactile examination of the hypotube revealed no signs of kinks or damage.An examination of the shaft polymer extrusion identified no issues.The bi-component bond showed no signs of damage or strain.There were no issues advancing the device over a 0.014¿ guidewire.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 investigation conclusion was unable to be determined.(b)(4).

Event Description

Reportable based on device analysis completed on 16-apr-2018.It was reported that stent was defective.Vascular access was obtained via the femoral artery.The 80% stenosed, 2.75mm in diameter, concentric, de novo target lesion was located in the moderately tortuous and moderately calcified ostial left circumflex and proximal to mid left anterior descending artery.Pre-dilation was performed with a 2.75x15 balloon catheter leaving a 50% residual stenosis.With the support of a non-bsc guide extension catheter, a 2.75x38mm promus element ¿ long drug-eluting stent was advanced to treat the lesion.However, stent was defective as the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal 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: 7500139
• MDR Text Key: 107829899
• Report Number: 2134265-2018-03828
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2018
• Device Model Number: H7493911338270
• Device Catalogue Number: 39113-3827
• Device Lot Number: 20851718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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 Weight: 68