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

Model Number H7493911320250

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the coronary artery.A 2.50x20mm promus element ¿ drug eluting stent was advanced to treat the lesion.However during the procedure, the stent was dislodged.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the f/g,promus element, mr, ous 2.50x20mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set correctly between the proximal and distal marker bands.The undamaged proximal stent od (outer diameter) was measured and is within maximum crimped stent profile.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 outer and the inner lumen, hypotube and mid-shaft section found no issues.The bi-component bond showed no signs of damage or strain.A visual and microscopic examination found no damage to the tip.No issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the coronary artery.A 2.50x20mm promus element ¿ drug eluting stent was advanced to treat the lesion.However during the procedure, the stent was dislodged.No patient 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: 6185608
• MDR Text Key: 62745778
• Report Number: 2134265-2016-11949
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: H7493911320250
• Device Catalogue Number: 39113-2025
• Device Lot Number: 18491539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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
• Patient Outcome(s): Other