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

Model Number H7493911332300

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/20/2017

Event Type  Injury  

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 dislodgement occurred.The target lesion was located in the left anterior descending artery (lad).A 3.00x32mm promus element ¿ drug-eluting stent was advanced but was 'impacted' into the lesion.When the device was removed, it was noted that the stent slipped off the balloon and was lost in the femoral artery.The procedure was completed with a different device.No further complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: promus element mr,ous, 3.0x32mm stent delivery system (sds) was returned.The stent slipped over balloon and lost in femoral artery therefore not returned for analysis.The maximum stent profile of the complaint device at the time of manufacture was reviewed and was verified to be within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.Balloon wings were in original folded position.Crimp stent markings were evident on the exposed proximal portion of the balloon wall, indicating that there was crimp contact between the coated stent and balloon at the time of manufacture.A visual and tactile examination found a hypotube break 15mm distal from the distal end of the strain relief and multiple hypotube kinks along the full catheter length.A visual and tactile examination found a kink and stretching to the inner shaft polymer extrusion 3mm distal to the bi-component bond.The bi-component bond showed no signs of damage or strain.A visual examination found no tip damage.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 is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the left anterior descending artery (lad).A 3.00x32mm promus element drug-eluting stent was advanced but was 'impacted' into the lesion.When the device was removed, it was noted that the stent slipped off the balloon and was lost in the femoral artery.The procedure was completed with a different device.No further complications were reported and the patient's status was stable.

• Brand Name: PROMUS ELEMENT ¿
• 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: 6750396
• MDR Text Key: 81295614
• Report Number: 2134265-2017-07943
• 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,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2018
• Device Model Number: H7493911332300
• Device Catalogue Number: 39113-3230
• Device Lot Number: 20262532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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 Outcome(s): Other