MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1120300-38

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number: e2019001.

Event Description

It was reported that the 3x38mm xience alpine stent delivery system (sds) was unable to connect to an unspecified inflation device.A new unspecified inflation device was opened, but the sds was still unable to connect.The device was not used and there was no patient involvement.Another unspecified abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified a leak in the sds, coming from a crack in the hub.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported leak was able to be confirmed.The reported loose or intermittent connection was unable to be 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 other incidents from this lot.As there was no report of a leak/bubbles during preparation for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the inflation device was over torqued during connection to the hub/sidearm of the stent delivery system, resulting in the noted hub break/crack; thus resulting in the reported loose/intermittent connection and the reported hub leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.Correction - patient code 2645 was removed and replaced with patient code 2199.

Event Description

Subsequent to the initially filed report, the following information was received: the 3x38mm xience alpine stent was used, and a leak was noticed during use by the presence of air bubbles.No additional information was provided.

• Brand Name: XIENCE ALPINE
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9156772
• MDR Text Key: 174529233
• Report Number: 2024168-2019-12361
• 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
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: 1120300-38
• Device Lot Number: 8090661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1