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

Catalog Number 1074300-38

Device Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354); Difficult To Position (1467); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a de novo lesion located in the moderately tortuous, mildly calcified, 75% stenosed distal right coronary artery.The 3.0-38 mm xience xpedition stent delivery system (sds) was advanced to the lesion in a direct-stenting attempt.When the sds balloon was inflated for the first time to 10 atmospheres it was thought that the sds balloon ruptured.The stent implant was deployed, but not fully expanded.The deployed stent was further dilated with the 3.0-15 mm trek rx balloon catheter; however, the dilatation balloon which was also thought to have ruptured when inflated for a third time.As the deployed stent was already satisfactorily expanded, no further attempts to dilate the stent were made.After retraction of the devices from the patient, further investigation observed leaks from the shafts of both devices at approximately the same location in each shaft; therefore, it was determined that balloon ruptures did not occur.It was commented that both devices met resistance either with associative devices or the guiding catheter which could have resulted in tearing/damage to the lumens.No adverse patient effects or clinically significant delay in the procedure were reported.

Manufacturer Narrative

(b)(4).Concomitant products: dil cath: trek rx 3.0-15; guide wire: sion blue; guide cath: terumo heartrail al-1 6f.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The trek referenced is being filed under a separate medwatch report.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The leak and tear in the shaft were able to be confirmed.The difficult to position and difficulty deploying the stent could not be replicated in a testing environment due to the condition of the returned device.Based on a visual and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the electronic complaint database revealed no other similar incidents reported for difficult to position, difficult to deploy, leak, or tears in the shaft from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE XPEDITION 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3919587
• MDR Text Key: 4666209
• Report Number: 2024168-2014-04400
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2014
• Device Catalogue Number: 1074300-38
• Device Lot Number: 211094B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR