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

Model Number	H7493952832250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.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 or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary graft to the left anterior descending (lad) artery.A 190 cm filterwire ez¿ was advanced to treat the lesion.However, during procedure, the filterwire failed to cross the lesion.The device was then removed and it was noted that the tip was damaged.Subsequently, another filterwire was advanced and was able to treat the lesion.A 2.50x32mm promus premier¿ stent was also advanced to treat the lad portion.Moreover, the shaft broke in half.The device was removed from the patient's body and the procedure was completed with another promus premier¿ stent.No patient complications reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage to the first proximal stent row and the stent struts lifted and pulled in a distal direction.The first distal stent row was also opened slightly.The undamaged crimped stent od (outer diameter) was measured which is within maximum crimped stent profile measurement.A visual and microscopic examination found tip damage.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 device found a break in the hypotube 738 mm distal from the distal end of the strain relief and multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion.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 or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary graft to the left anterior descending (lad) artery.A 190 cm filterwire ez¿ was advanced to treat the lesion.However, during procedure, the filterwire failed to cross the lesion.The device was then removed and it was noted that the tip was damaged.Subsequently, another filterwire was advanced and was able to treat the lesion.A 2.50x32mm promus premier¿ stent was also advanced to treat the lad portion.Moreover, the shaft broke in half.The device was removed from the patient's body and the procedure was completed with another promus premier¿ stent.No patient complications reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6500930
• Report Number: 2134265-2017-03577
• Device Sequence Number: 18855797
• Product Code: NIQ
• UDI-Device Identifier: 08714729844952
• UDI-Public: (01)08714729844952(17)20171014(10)0019186534
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: H7493952832250
• Device Catalogue Number: 39528-3225
• Device Lot Number: 0019186534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1