MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1011710-38

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: terumo runthrough floppy, whisper extra support.Inflation: b.Braun.Guide catheter: terumo climber.Sheath: terumo radifocus.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a narrow lesion with moderate tortuosity and mild calcification in the proximal left anterior descending (lad) coronary artery.A non-abbott guide wire was advanced to the target lesion and the 3.5 x 38 mm xience prime stent delivery system (sds) was advanced, but could not cross the lesion.Dilatation was performed using a 3.0 x 15 mm trek balloon, and a second attempt was made to cross the lesion with the xience prime sds but was unsuccessful.A 3.5 guiding catheter was switched to a 4.5 guiding catheter.A buddy-wire technique was used, adding a whisper extra support guide wire, but was not successful.It was further reported that once the xience prime sds had exited the guiding catheter, there was difficulty moving the sds forward and back with both guide wires, especially on the whisper guide wire.The procedure was completed using a non-abbott sds with the whisper guide wire successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported difficulty positioning and removing the guide wire could not be confirmed.The reported failure to advance could not be replicated in a testing environment as it was due to circumstances of the procedure.The xience prime everolimus eluting coronary stent system, instructions for use (ifu) states: the vessel should be pre-dilated with an appropriate sized balloon.Failure to do so may increase the difficulty of stent placement and cause procedural complications.The ifu also states: an unexpanded stent may be retracted into the guiding catheter one time only.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the stent delivery system (sds) was unable to cross (failure to advance) the narrow lesion with moderate tortuosity and mild calcification without pre-dilation.Additionally, it is likely the sds met resistance during positioning and removing from the guide wire due to a build up of procedural contaminants (blood, contrast) thus causing the reported resistance.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7073504
• MDR Text Key: 94211370
• Report Number: 2024168-2017-09304
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GG
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Catalogue Number: 1011710-38
• Device Lot Number: 6072541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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 Age: 54 YR
• Patient Weight: 90