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

Model Number H7493925128270

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

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 mdr will be filed. (b)(4).

Event Description

Same case as mdr id: 2134265-2018-05635.It was reported that stent damage occurred.Vascular access was obtained via right radial artery with a 3.0 6f non-bsc guiding catheter.The 80% stenosed, 28mm x 2.75-3.00mm, de novo target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending artery before the first diagonal branch.Following pre-dilatation with 2.00 x 12 and 2.50 x 15 emerge balloon catheters, the physician advanced a 2.75 x 28 synergy¿ stent but it could not be delivered to the target lesion.Upon retrieval of the device, it was noticed that some stent struts were deformed.Subsequently, the physician proceeded to prepare the lesion further with a 3.00 x 15 non-bsc balloon catheter.Following further pre-dilatation, a 28 x 2.75 promus premier¿ stent was advanced but still could not be delivered.Upon retrieval, the stent struts were noticed to be deformed as well.The lesion was further prepared using a 3.00 x 15 non-bsc balloon catheter and a high pressure 3.00 x 12 nc emerge ballon catheter.A buddy wire was used to deploy two shorter stents, a 2.50 x 16 synergy¿ and a 3.00 x 24 promus premier¿, respectively.Post-dilatation was performed with a 3.00 x 12 nc emerge balloon catheter and the procedure was completed.No patient complications were reported and the patient's status was stable.

Event Description

Same case as mdr id: 2134265-2018-05635.It was reported that stent damage occurred.Vascular access was obtained via right radial artery with a 3.0 6f non-bsc guiding catheter.The 80% stenosed, 28mm x 2.75-3.00mm, de novo target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending artery before the first diagonal branch.Following pre-dilatation with 2.00 x 12 and 2.50 x 15 emerge balloon catheters, the physician advanced a 2.75 x 28 synergy stent but it could not be delivered to the target lesion.Upon retrieval of the device, it was noticed that some stent struts were deformed.Subsequently, the physician proceeded to prepare the lesion further with a 3.00 x 15 non-bsc balloon catheter.Following further pre-dilatation, a 28 x 2.75 promus premier stent was advanced but still could not be delivered.Upon retrieval, the stent struts were noticed to be deformed as well.The lesion was further prepared using a 3.00 x 15 non-bsc balloon catheter and a high pressure 3.00 x 12 nc emerge balloon catheter.A buddy wire was used to deploy two shorter stents, a 2.50 x 16 synergy and a 3.00 x 24 promus premier, respectively.Post-dilatation was performed with a 3.00 x 12 nc emerge balloon catheter and the procedure was completed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus premier ous mr 28 x 2.75mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found proximal stent damage.Proximal stent struts were pushed distally.The undamaged section of the crimped stent outer diameter was measured and the result was within 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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7637806
• MDR Text Key: 112322824
• Report Number: 2134265-2018-05634
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: H7493925128270
• Device Catalogue Number: 39251-2827
• Device Lot Number: 20946085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: HEARTRAIL BL3.0 6F; GUIDE CATHETER: HEARTRAIL BL3.0 6F