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

Catalog Number 1550225-28

Device Problems Inflation Problem (1310); Material Rupture (1546); Difficult or Delayed Activation (2577); Patient-Device Incompatibility (2682); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4) 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.Estimated date of event: estimated date of implant.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the 2.25 x 28 mm xience sierra stent delivery system (sds) was advanced to the right coronary artery slightly more distal than the intended area.The stent was ready to be deployed but the sds balloon would not inflate when a normal rate of inflation was used.The inflation device was quickly inflated to 10 atmospheres which allowed the stent to be partially deployed (dog-boned), but the sds was losing pressure.The dog boned stent was due to the slow leak on the sds balloon.During removal of the sds, the stent was inadvertently pulled back 10 mm.A 2.0 x 20 balloon dilatation catheter was inserted through the stent to more fully expand it against the artery.The stent was still covering the intended lesion.A 2.5 mm non-compliant bdc was used to post dilate the stent.After the sds was removed from the anatomy, the balloon rupture was noted.The customer believes the balloon rupture occurred from the stent itself at the manufacturing site.The procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.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 inflation problem, material rupture and difficult or delayed activation were confirmed.The reported device incompatibility (wall apposition) could not be replicated in a testing environment as it was related to operational context of the procedure.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 material rupture.The reported inflation problems, delayed activation and device compatibility (wall apposition) appear to be related to operational context of the procedure as it is likely the reported material rupture and noted inner member damage likely caused the reported inflation issues, delayed activation, and device compatibility (wall apposition).It should be noted that there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9227361
• MDR Text Key: 163587431
• Report Number: 2024168-2019-12895
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227042
• UDI-Public: 08717648227042
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Catalogue Number: 1550225-28
• Device Lot Number: 9071142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR