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

Catalog Number 1120225-15

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a right coronary artery.A 2.25x15mm rx xience alpine stent delivery system (sds) was positioned in the lesion and during inflation the balloon only partially inflated as contrast leaked from an unknown location.The sds with the stent was removed and a new same size xience alpine was used to successfully complete the procedure.Reportedly, the first xience alpine was not prepped prior to use.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1546 labeled.Internal file number - (b)(4).Mfr site - contact office first and last name was updated from connie speck to lindsey bell.Registration number for clonmel was updated from (b)(4) to (b)(4).Device code 1354 was removed and 1546 added.Evaluation summary: the device was returned for analysis.The reported material rupture and inflation issues were confirmed.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.It should be noted that device preparation was not performed outside of the anatomy, prior to use.Visual inspection and device preparation are performed prior to use to prepare the device for inflation and to ensure no quality issues are present prior to use.The xience alpine everolimus eluting coronary stent system (eecss), instructions for use, states: system preparation to be performed prior to delivery procedure.The investigation was unable to determine a conclusive cause for the reported material rupture.The reported inflation issues appear to be related to operational context of the procedure as it is likely the material rupture caused the reported inflation issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed mdr report, the balloon was partially inflated when a leak [rupture] was noted at nominal pressure.No additional information was provided.

• Brand Name: XIENCE ALPINE 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
• MDR Report Key: 8745635
• MDR Text Key: 149637680
• Report Number: 2024168-2019-05227
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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: 11/07/2020
• Device Catalogue Number: 1120225-15
• Device Lot Number: 7102741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 65