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

Model Number	H7493952832350
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-07127.It was reported that stent damage occurred.The target lesion was located in the left anterior descending (lad) artery.A 1.25mm rotalink¿ plus was advanced to perform ablation.The device was able to do two passes; however, on the third pass, the device kept stalling.The physician checked all the connections, including the drip and everything was fine.The device was removed from the patient's body and it was noted that the metal sheath that covers the spring on the rotablator was torn.Ablation was completed with a 1.5mm rotalink¿ plus.Following ablation, a 3.50x32mm promus premier¿ drug-eluting stent was advanced with a non-bsc guide extension catheter in place and two guide wires across the lesion.However, the device could not pass through the non-bsc guide extension catheter.The device was removed from the patient's body and the stent was noted to be shredded up.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.Fg promus premier us mr 3.50x32mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found proximal stent damage.Proximal end of stent was damaged and squashed.The undamaged section of the crimped stent od (outer diameter) was measured and was within the maximum crimped stent profile measurement.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 identified multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.A visual and microscopic examination found that there was 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 cause of the reported difficulties may be due to interaction with another device.Bsc id #: (b)(4).Tw#: (b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-07127.It was reported that stent damage occurred.The target lesion was located in the left anterior descending (lad) artery.A 1.25mm rotalink¿ plus was advanced to perform ablation.The device was able to do two passes; however, on the third pass, the device kept stalling.The physician checked all the connections, including the drip and everything was fine.The device was removed from the patient's body and it was noted that the metal sheath that covers the spring on the rotablator was torn.Ablation was completed with a 1.5mm rotalink¿ plus.Following ablation, a 3.50x32mm promus premier¿ drug-eluting stent was advanced with a non-bsc guide extension catheter in place and two guide wires across the lesion.However, the device could not pass through the non-bsc guide extension catheter.The device was removed from the patient's body and the stent was noted to be shredded up.The procedure was completed with a different device.No patient complications were 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: 6722660
• Report Number: 2134265-2017-07135
• Device Sequence Number: 16189795
• Product Code: NIQ
• UDI-Device Identifier: 08714729844983
• UDI-Public: (01)08714729844983(17)20171225(10)19443670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/28/2017

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: 12/25/2017
• Device Model Number: H7493952832350
• Device Catalogue Number: 39528-3235
• Device Lot Number: 19443670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR