MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070350-48

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 deflation issues.Additionally, the reported difficulty to remove and detachment of a device component appear to be related to operational context as several attempts were made to deflate the device and were unsuccessful causing the reported difficulty to remove.The device was removed inflated causing the reported detachment of a device component.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 48 is currently not commercially available in the u.S.However, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat a 100% stenosed, chronic totally occluded (cto), and heavily calcified lesion in the mid right coronary artery (rca).A 3.5x48mm xience xpedition stent was deployed; however, the balloon failed to deflate even after several attempts.Troubleshooting was performed by attempting to puncture the balloon with many different tools, but it was unsuccessful even when a second balloon was placed next to it.The attempts to remove the delivery system with the inflated balloon was made for more than four hours with no success.An attempt to pull out the inflated balloon was made; however, the shaft separated.The balloon was left in the mid rca.The patient is fine because the lesion was already cto.No additional information was provided.

Manufacturer Narrative

Device codes: 1255 not labeled.Internal file number (b)(4).B5 continued: after injecting local anesthesia on the middle forearm, transcutaneous puncture of the balloon through the skin and the radial artery wall was performed with a 23-gauge syringe needle using fluoroscopy for guidance, and contrast media were aspirated with the syringe.Retrieval of the deflated balloon was then possible through the radial sheath.Reintubation of the rca with a fresh guiding catheter revealed a good angiographic result in the proximal segment and relevant acute recoil at the ostium of the calcified rca.Implantation of a second short 4.0x9mm non-abbott stent was necessary to mechanically stabilize the lesion.Injection of contrast media through the sheath confirmed the integrity of the radial artery at the puncture site.Radial compression was used to close the 6f access site.The clinical follow-up remained uneventful.No additional information was provided.Guide cath: 5f amplatz l1.Guide wire: biotronik galeo es.Sheath: 6f terumo glidesheath.Device code 1104 and patient code 2687 were removed.Additional evaluation: the reported information was reviewed.The reported unusual balloon fold appears to be related to operational context as several attempts were made to deflate the device and were unsuccessful causing the reported difficulty to remove and subsequent patient effects of additional therapy/non-surgical treatment and delayed treatment.During attempted removal the device was manipulated by a forced pullback and interacted with the anatomy causing the unusual balloon fold appearance.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: article titled - transcutaneous puncture of an undeflatable coronary angioplasty balloon catheter.- attachment: [literature 349989 mre_1-009001ea480405694.Pdf].

Event Description

Subsequent to the previously filed report, the following additional information was received via a research article, titled "transcutaneous puncture of an undeflatable coronary angioplasty balloon catheter." details are listed in the attached article.Following pre-dilatation, a 3.5x48mm xience xpedition drug-eluting stent (des) was deployed at 18 atmospheres.A mixture of contrast media and saline at a ratio of 1:1 was used.After a second more proximal inflation, the balloon delivery catheter did not deflate completely and it could not be pulled back into the 5f guiding catheter.Excessive inflation and deflation with the indeflator and forced aspiration with a 50 ml syringe were unable to deflate the balloon that was stuck at the rca ostium.It was then decided to pull back the entire equipment including the guiding catheter, guide wire, and stent balloon at once.Finally, the balloon catheter became released from the stent remaining in place in the coronary artery.An attempt to burst the balloon in the ascending aorta by inflation well over rated burst pressure, as well as puncturing the balloon within the guide catheter with multiple stiff guide wires, also failed.During a further pullback of the system, the still inflated balloon became stuck again in the small and vasospastic radial artery.The balloon could not be pulled or pushed in any direction and was unable to wedge the balloon into the 6f radial sheath.Moreover, a forced pullback of the partially inflated balloon catheter resulted in invagination of the distal part of the balloon.

• Brand Name: XIENCE XPEDITION 48 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: 7587210
• MDR Text Key: 110634093
• Report Number: 2024168-2018-04359
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Catalogue Number: 1070350-48
• Device Lot Number: 8020641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR