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

Model Number H7493911316270

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 20mm in length, concentric, de novo target lesion was located in the non-tortuous, non-calcified and 2.75mm in diameter 1st diagonal branch of the left anterior descending (lad) artery.After placing a 6f non-bsc guide catheter, two non-bsc guide wires were crossed, one in the lad and the other one in the 1st diagonal branch.A promus element plus 7.75*28 was centralized at the site of the distal lad lesion and deployed at 14atm.A promus element plus 30*28 was centralized at the 1st site of the mid lad lesion and deployed at 16atm.Then attention was turned to the lesion located in the 1st diagonal.Following pre-dilatation at 16 atmospheres (atm) using a 1.5*15mm non-bsc balloon, a 2.75x16mm promus element¿ stent was advanced but failed to cross and the stent was noted to be distorted.A 2.75*12mm promus element plus stent was then deployed in the 1st diagonal at 16 atm and a 3.0*15mm quantum apex balloon catheter was positioned in the lad.Final kissing balloon was then performed with the stent balloon catheter in the 1st diagonal and the quantum balloon in the lad at 8 atm.Final angiogram shows timi flow iii without edge dissection nor residual stenosis and the procedure was completed.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 20mm in length, concentric, de novo target lesion was located in the non-tortuous, non-calcified and 2.75mm in diameter 1st diagonal branch of the left anterior descending (lad) artery.After placing a 6f non-bsc guide catheter, two non-bsc guide wires were crossed, one in the lad and the other one in the 1st diagonal branch.A promus element plus 7.75*28 was centralized at the site of the distal lad lesion and deployed at 14atm.A promus element plus 30*28 was centralized at the 1st site of the mid lad lesion and deployed at 16atm.Then attention was turned to the lesion located in the 1st diagonal.Following pre-dilatation at 16 atmospheres (atm) using a 1.5*15mm non-bsc balloon, a 2.75x16mm promus element ¿ stent was advanced but failed to cross and the stent was noted to be distorted.A 2.75*12mm promus element plus stent was then deployed in the 1st diagonal at 16 atm and a 3.0*15mm quantum apex balloon catheter was positioned in the lad.Final kissing balloon was then performed with the stent balloon catheter in the 1st diagonal and the quantum balloon in the lad at 8 atm.Final angiogram shows timi flow iii without edge dissection nor residual stenosis and the procedure was completed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: f/g,promus element,mr,ous 2.75x16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.The distal to mid-section of the stent was stretched in a distal direction, such that the distal end was stretched over the distal markerband.The undamaged section of the crimped stent od (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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.  (b)(4).

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7652653
• MDR Text Key: 112849822
• Report Number: 2134265-2018-05851
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 06/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2018
• Device Model Number: H7493911316270
• Device Catalogue Number: 39113-1627
• Device Lot Number: 0020153506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6F XB; GUIDE WIRE: ASAHI SOFT
• Patient Age: 61 YR
• Patient Weight: 75