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

Model Number H7493918438250

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 2.50x38mm promus element¿ plus drug-eluting stent was advanced but failed to cross the target lesion.The device was removed and it was noted that the stent was deformed.Another 2.50x38mm promus element¿ plus drug-eluting stent was advanced but also failed to cross the lesion.The procedure was completed with two shorter stents.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

  device evaluated by mfr: f/g, promus element plus, mr,ous 2.50x38mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found proximal stent damage.The most proximal stent strut was lifted from the stent profile and bent back distally.The crimped stent od(outer diameter) of the undamaged portion of the stent was measured.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.A visual and tactile examination of the hypotube revealed multiple hypotube kinks.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues.The bi-component bond showed no signs of damage or strain.A visual examination found no damage to the tip.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

It was reported that stent damage occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 2.50x38mm promus element¿ plus drug-eluting stent was advanced but failed to cross the target lesion.The device was removed and it was noted that the stent was deformed.Another 2.50x38mm promus element¿ plus drug-eluting stent was advanced but also failed to cross the lesion.The procedure was completed with two shorter stents.No patient complications were reported and the patient's status was stable.

• 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: 6184791
• MDR Text Key: 62673591
• Report Number: 2134265-2016-11881
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2017
• Device Model Number: H7493918438250
• Device Catalogue Number: 39184-3825
• Device Lot Number: 18423434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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