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

Catalog Number 1128275-33

Device Problems Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that on (b)(6) 2019, a 2.75x33mm xience pro stent was implanted in the mid left anterior descending (lad) coronary artery lesion.Post dilatation was performed and proximal stent malformation with stent malposition were observed.Reportedly, this was induced by the post-dilatation balloon.As treatment, additional balloon dilatation was performed, resolving the issue.There was no adverse patient sequela.No additional information was provided regarding this event.

Manufacturer Narrative

Internal file number - (b)(4).The xience proa is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The device was not returned for analysis.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy.The reported material deformation and device damaged by another appear to be related to circumstances of the procedure as it is likely the device interacted with the post-dilatation balloon causing the reported device damaged by another and subsequent material deformation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Internal file number - (b)(4).

Event Description

Subsequent to the previous medwatch report, the additional information was obtained: following implantation of the 2.75x33mm xience pro stent, stent expansion was <90% in the distal half and malapposition was at the proximal edge.The operator decided to treat the distal half only.Following, the 3.0 non-compliant balloon possibly caused stent deformation at the proximal edge.The proximal malapposition was not treated.It was decided to treat the proximal stent portion in 4 weeks.On (b)(6) 2019, a 3.5x12mm xience proa stent was placed proximally.Post implantation, the stent expansion was at 92%.The maximum sized balloon at high pressure was used.

• Brand Name: XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8489088
• MDR Text Key: 141110088
• Report Number: 2024168-2019-02702
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: 1128275-33
• Device Lot Number: 8011741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6F; GUIDE CATHETER: 6F
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 82