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

Catalog Number 1550300-15

Device Problems Deflation Problem (1149); Material Rupture (1546); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide catheter: 7fr spb; stent: resolute onyx 2.75 x 18 mm.The device was received.The investigation is not yet complete.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 concentric, de novo lesion in the first diagonal branch of the left anterior descending coronary artery with no tortuosity, no calcification and 90% stenosis.A previously deployed stent was crossing the first diagonal branch.Following pre-dilatation, a 2.75 x 18 mm non-abbott stent was deployed at the distal side of the lesion.A 3.00 x 15 mm xience sierra stent delivery system (sds) was advanced with no resistance for deployment proximally to overlap the non-abbott stent.On deploying the stent of the sds, contrast was noted to leak out distally from the balloon at 12 atmospheres.The stent was deployed; however, was noted to not be fully apposed to the vessel wall.Despite insufficient deflation of the balloon, the sds was removed with the balloon partially deflated without issue and the non-abbott sds balloon was re-advanced to successfully post dilate the stent.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: mfr site registration #.Evaluation summary: the device was returned for analysis.The reported material rupture was confirmed.The reported deflation issue and difficult to deploy could not be confirmed due to the condition of the device.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 determined the reported material rupture appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: XIENCE SIERRA 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: 8574939
• MDR Text Key: 143873435
• Report Number: 2024168-2019-03486
• 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
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2021
• Device Catalogue Number: 1550300-15
• Device Lot Number: 8080241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 07/13/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCOMITANT MEDICAL DEVICES; CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Required Intervention