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

Model Number H7493918438350

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus element plus,mr,ous 3.50 x 38 mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Damage was noted to central and proximal stent strut rows.The stent showed no signs of movement and was set equidistant between the proximal and distal marker bands.The crimped stent outer diameter (od) of the undamaged distal stent was measured and the result was within maximum crimped stent profile measurement.The length of the crimped stent was measured and the result was within the crimped stent length specification.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.Balloon was inflated to rated burst pressure (rbp) with encore inflation device with no issues.The stent expanded with no issues.A vacuum was then pulled and the balloon deflated with no issues in 4 seconds and the result was within the deflation time specified in the dfu.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion revealed no issues.The bi-component bond showed no signs of damage or strain.The device was tracked over a 0.014¿¿ guidewire and no issues or resistances were noted.A visual and microscopic examination of the tip found no damage.No other issues were identified during analysis.There is no evidence that the device failed to meet specification prior to shipping therefore an additional dhr review is not required at this time.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 17-aug-2017.It was reported that the stent was faulty.The target lesions was located in the left anterior descending (lad) artery.A 3.50 x 38 mm promus element¿ plus drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was noted to be faulty.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed stent damage.

• 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: 6846284
• MDR Text Key: 85603782
• Report Number: 2134265-2017-08715
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P110010
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2018
• Device Model Number: H7493918438350
• Device Catalogue Number: 39184-3835
• Device Lot Number: 19854406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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
• Patient Age: 47 YR