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

Catalog Number 1070350-38

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: pilot50 190cm.Guide cath: ebu 3,75 6f medtronic.Stents: 2.75x38mm xience xpedition.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 a 2.75x38mm xience xpedition stent was implanted at the mid left anterior descending (lad) and a 3.5x38mm xience xpedition stent was implanted at the left main (lm) to proximal lad coronary artery lesion.Reportedly, the stent was well apposed to the vessel wall.Following deployment, difficulty was noted during device removal of the 3.5x38mm xience xpedition delivery system and the catheter shaft separated.The difficulty was due to anatomy and the shaft was retrieved via snare.Reportedly, there was a significant delay; however, there were no adverse patient effects.The patient was reported to be in good condition.There was no additional information provided.

Manufacturer Narrative

(b)(4).The stent was deployed with 2 inflations at 20 atmospheres which is above rated burst pressure(rbp).(b)(4).Evaluation summary: the device was returned for analysis and the reported shaft separation was confirmed.The difficult to position and difficult to remove could not be replicated in a testing environment as it was based on operational circumstances.Based on the visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.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 identified no other similar incidents reported from this lot.It was reported the device was inflated above the rated burst pressure.It should be noted the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: do not exceed rated burst pressure as indicated on product label.Balloon pressures should be monitored during inflation.Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and dissection.The reported violation of the ifu does not appear to have caused or contributed to the complaint.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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 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: 5142669
• MDR Text Key: 28026025
• Report Number: 2024168-2015-05981
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2018
• Device Catalogue Number: 1070350-38
• Device Lot Number: 5031141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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: 82 YR
• Patient Weight: 100