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

Model Number H7493918424400

Device Problems Premature Activation (1484); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

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 the stent was deployed prematurely and dislodgment occurred.Vascular access was obtained via the femoral artery.The 4.0 x 22mm in length, de novo target lesion was located in the non tortuous and severely calcified left anterior descending artery.A 4.00 x 24mm promus element¿ plus drug-eluting stent was advanced to treat the lesion.However, it was noted that the half of the stent was deployed in the catheter.The whole stent delivery system was removed.Stent came out with the catheter, but the stent is not intact in the balloon system.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable and doing good.

Manufacturer Narrative

Device evaluated by mfr: promus element plus,mr,ous 4.00x24mm stent delivery system (sds) was returned for analysis with the stent detached from the device.Stent detached from sds.One end of the stent was damaged with stent struts squashed.Minimal damage received on the other end of the stent.The undamaged stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed.There was no stent on the balloon.The balloon folds were present but were not tightly wrapped; it did not appear that the balloon had been subjected to positive pressure.Crimp markings were evident on the balloon indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found no damage.No other issues were identified during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that the stent was deployed prematurely and dislodgment occurred.Vascular access was obtained via the femoral artery.The 4.0 x 22mm in length, de novo target lesion was located in the non tortuous and severely calcified left anterior descending artery.A 4.00 x 24mm promus element plus drug-eluting stent was advanced to treat the lesion.However, it was noted that the half of the stent was deployed in the catheter.The whole stent delivery system was removed.Stent came out with the catheter, but the stent is not intact in the balloon system.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable and doing good.

• 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: 7732758
• MDR Text Key: 115489357
• Report Number: 2134265-2018-06743
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• 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,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: H7493918424400
• Device Catalogue Number: 39184-2440
• Device Lot Number: 21863993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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